CN107860839B - Method for separating and determining two drugs and bacteriostatic agent in naftifine ketoconazole cream by HPLC method - Google Patents

Method for separating and determining two drugs and bacteriostatic agent in naftifine ketoconazole cream by HPLC method Download PDF

Info

Publication number
CN107860839B
CN107860839B CN201711064092.XA CN201711064092A CN107860839B CN 107860839 B CN107860839 B CN 107860839B CN 201711064092 A CN201711064092 A CN 201711064092A CN 107860839 B CN107860839 B CN 107860839B
Authority
CN
China
Prior art keywords
naftifine
ketoconazole
mobile phase
solution
bacteriostatic agent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CN201711064092.XA
Other languages
Chinese (zh)
Other versions
CN107860839A (en
Inventor
刘春芝
杨平
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chongqing Huapont Pharm Co Ltd
Original Assignee
Chongqing Huapont Pharm Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Chongqing Huapont Pharm Co Ltd filed Critical Chongqing Huapont Pharm Co Ltd
Priority to CN201711064092.XA priority Critical patent/CN107860839B/en
Publication of CN107860839A publication Critical patent/CN107860839A/en
Application granted granted Critical
Publication of CN107860839B publication Critical patent/CN107860839B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/04Preparation or injection of sample to be analysed
    • G01N30/06Preparation

Landscapes

  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The invention belongs to the field of analytical chemistry, and particularly relates to a method for separating and determining two drugs and a bacteriostatic agent in naftifine ketoconazole cream by using an HPLC (high performance liquid chromatography) method. The chromatographic column adopted by the method is characterized in that octadecylsilane chemically bonded silica is used as a filler, mobile phase A and mobile phase B are adopted for gradient elution, and the gradient elution enters a detector for detection; the two medicines are naftifine hydrochloride and ketoconazole, and the bacteriostatic agent is potassium sorbate; the mobile phase A is an aqueous solution of an ion pair reagent, and the mobile phase B is an organic solvent. The method can simultaneously separate and determine the contents of two medicines and the bacteriostatic agent in the naftifine ketoconazole cream; the method has good repeatability, the determination is not interfered by solvent peaks in the detection, two medicines and bacteriostatic agents in the naftifine ketoconazole cream can be effectively separated from related substances, the separation degree is more than 2.0, the detection result is accurate and reliable, and the method has important significance for realizing the quality control of the naftifine ketoconazole cream.

Description

Method for separating and determining two drugs and bacteriostatic agent in naftifine ketoconazole cream by HPLC method
Technical Field
The invention belongs to the field of analytical chemistry, and particularly relates to a method for separating and determining two drugs and a bacteriostatic agent in naftifine ketoconazole cream by using an HPLC (high performance liquid chromatography) method.
Background
The naftifine ketoconazole cream is a compound preparation for treating fungal dermatopathy, contains naftifine hydrochloride and ketoconazole, is a brand new compound preparation consisting of 0.1 percent of naftifine hydrochloride and 0.25 percent of ketoconazole, and is mainly used for tinea manus and pedis, tinea corporis and cruris, tinea capitis, cutaneous candidiasis and the like.
Both naftifine hydrochloride and ketoconazole can inhibit the synthesis of ergosterol from fungal cell membranes, so that the membrane structure is destroyed, and the growth of fungal cells is inhibited. However, the mechanisms that influence ergosterol synthesis are different: ketoconazole acts on C-14 demethylase of wool steroid, and inhibits the conversion of wool steroid to 14-demethyl wool steroid, thereby inhibiting the synthesis of ergosterol, and has antibacterial and bactericidal effects on dermatophyte, yeast, etc. Naftifine hydrochloride acts on squalene epoxidase as a target, inhibits the conversion of squalene into squalene epoxide, and finally inhibits the biosynthesis of ergosterol. Furthermore, the accumulation of squalene causes the cell membrane to be ruptured with increased fragility. The allylamines have strong bactericidal activity against dermatophytes, and have bacteriostatic action against yeasts.
Both naftifine hydrochloride and ketoconazole are clinically effective medicaments for treating fungal dermatosis, and clinical research results show that the synergistic effect of the naftifine hydrochloride and the ketoconazole at the concentration is enhanced, the adverse reaction is less, and the recurrence rate is low.
The naftifine ketoconazole cream is a compound preparation, and the potassium sorbate is a bacteriostatic agent of the cream, so that the growth of bacteria can be inhibited, and the storage life of the medicine is prolonged. The existing method is to detect naftifine hydrochloride and ketoconazole respectively. So far, no published method reports that two medicaments and bacteriostatic agents in the naftifine ketoconazole cream can be effectively separated and quantitatively determined.
Therefore, the development of a method for simultaneously separating and determining the contents of two medicaments and the bacteriostatic agent in the naftifine ketoconazole cream has extremely important significance for realizing the quality control and the effectiveness guarantee of the naftifine ketoconazole cream.
Disclosure of Invention
In view of the above, the invention aims to provide a method for separating and determining two drugs and a bacteriostatic agent in a naftifine ketoconazole cream by using an HPLC method, the method can simultaneously separate and determine the contents of the two drugs and the bacteriostatic agent in the naftifine ketoconazole cream, has good repeatability, does not interfere with the determination of a solvent peak in the detection, has accurate and reliable detection results, and has important significance for realizing the quality control of the naftifine ketoconazole cream.
In order to achieve the purpose, the technical scheme of the invention is as follows:
separating and determining two drugs and bacteriostatic agents in the naftifine ketoconazole cream by using an HPLC method, wherein a chromatographic column adopted by the method takes octadecylsilane chemically bonded silica as a filler, and adopts a mobile phase A and a mobile phase B for gradient elution, and the chromatographic column enters a detector for detection; the two medicines are naftifine hydrochloride and ketoconazole, and the bacteriostatic agent is potassium sorbate;
the mobile phase A is an aqueous solution of an ion pair reagent, and the mobile phase B is an organic solvent.
Further, the aqueous solution of the ion pair reagent contains one or more of potassium hexafluorophosphate, tetrabutylammonium hydrogen sulfate and tetrabutylammonium bromide.
Preferably, the ion-pairing reagent in the aqueous solution of the ion-pairing reagent is one of potassium hexafluorophosphate, tetrabutylammonium hydrogen sulfate and tetrabutylammonium bromide.
Preferably, the ion-pairing agent in the aqueous solution of the ion-pairing agent is potassium hexafluorophosphate and tetrabutylammonium bromide.
Preferably, the ion-pairing reagent in the aqueous solution of the ion-pairing reagent is tetrabutylammonium bromide.
Further, the concentration of the aqueous solution of the ion pair reagent is 15-25 mmol/L. The pH of the aqueous solution of the ion pair reagent is 2.9-4.5.
Preferably, the concentration of the aqueous solution of the ion-pairing reagent is 20 mmol/L. The concentration of the aqueous ion-pairing reagent solution can also be expressed as a 0.05% solution by mass.
Further, the organic solvent is acetonitrile or a mixture of acetonitrile and methanol; the volume ratio of acetonitrile to methanol in the organic solvent is 100:0-70: 30.
Preferably, the organic solvent is a mixture of acetonitrile and methanol, and the volume ratio of the acetonitrile to the methanol is 70: 30.
Further, the gradient elution was set as follows:
Figure BDA0001455376840000031
the flow rate of the mobile phase for elution is 0.9-1.1 ml/min.
As a preference, the gradient elution is set as follows:
Figure BDA0001455376840000032
the flow rate of the mobile phase for elution is 1 ml/min; the sample amount of the sample solution is 10 to 30. mu.l, preferably 20. mu.l.
Further, the specification of the column was 4.6X 150mm, 5 μm. The temperature of the chromatographic column is 20-35 ℃.
Further, the detection wavelength of the detector is 220-260 nm.
Preferably, the detection wavelength of the detector is 250 nm.
Further, the method for separating and determining the two drugs and the bacteriostatic agent in the naftifine ketoconazole cream by the HPLC method specifically comprises the following steps:
1) preparing a blank solution: taking a solvent as a blank solution;
2) preparing a test sample solution: dissolving a sample to be tested in a solvent to obtain a sample solution;
3) preparing a reference solution: dissolving naftifine hydrochloride reference substance, ketoconazole reference substance and potassium sorbate reference substance in a solvent for dilution to prepare a reference substance solution;
4) respectively taking the blank solution in the step 1), the step 2) the sample to be tested and the step 3) the reference solution is injected, carrying out high performance liquid chromatography analysis, recording a chromatogram, determining the retention time of two drugs and the bacteriostatic agent in the naftifine ketoconazole cream, and calculating the contents of the two drugs and the bacteriostatic agent in the naftifine ketoconazole cream in the sample to be tested by a peak area according to an external standard method.
The recorded chromatograms sequentially comprise potassium sorbate, ketoconazole and naftifine hydrochloride according to the peak appearance sequence; the theoretical plate number is not less than 50000 calculated according to potassium sorbate peak, not less than 50000 calculated according to ketoconazole peak, and not less than 50000 calculated according to naftifine hydrochloride peak.
Further, the solvent in the steps 1) to 3) is methanol with a volume fraction of 80%.
The invention also aims to provide a reagent composition for determining the contents of two medicines and a bacteriostatic agent in naftifine ketoconazole cream by solid-liquid separation, which consists of the following reagents:
reagent A: an aqueous solution of an ion-pairing reagent;
and (3) reagent B: acetonitrile or a mixture of acetonitrile and methanol;
the two medicines are naftifine hydrochloride and ketoconazole, and the bacteriostatic agent is potassium sorbate;
the concentration of the aqueous solution of the ion pair reagent is 20 mmol/L;
the volume ratio of acetonitrile to methanol in the reagent B is 100:0-70: 30;
the aqueous solution of the ion pair reagent contains one or more of potassium hexafluorophosphate, tetrabutylammonium hydrogen sulfate and tetrabutylammonium bromide.
As a preference, the reagent composition consists of the following reagents:
reagent A: 0.05 percent of tetrabutylammonium bromide aqueous solution;
and (3) reagent B: a mixture of acetonitrile and methanol in a volume ratio of 70: 30.
The two medicines and the bacteriostatic agent in the naftifine ketoconazole cream can be simultaneously separated and determined by adopting the reagent composition and adopting a high performance liquid chromatography.
The invention has the beneficial effects that:
1) the method for separating and determining the two drugs and the bacteriostatic agent in the naftifine ketoconazole cream by the HPLC method can simultaneously separate and determine the contents of the two drugs and the bacteriostatic agent in the naftifine ketoconazole cream, the method has good repeatability, a solvent peak in the detection does not interfere with the determination, the two drugs and the bacteriostatic agent in the naftifine ketoconazole cream can be effectively separated from related substances, the separation degree is more than 2.0, and the detection result is accurate and reliable.
2) The reagent composition provided by the invention can effectively separate the naftifine ketoconazole cream and two drugs and bacteriostatic agents in the naftifine ketoconazole cream, and has important significance for realizing the quality control of the naftifine ketoconazole cream.
Drawings
FIG. 1 is a high performance liquid chromatogram of naftifine ketoconazole cream blank matrix.
Fig. 2 is a high performance liquid chromatogram of a naftifine ketoconazole mirophora cream sample.
Detailed Description
Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. The experimental methods of the preferred embodiments, which do not indicate specific conditions, are generally performed according to conventional conditions, and the examples are given for better illustration of the present invention, but the present invention is not limited to the examples. Therefore, those skilled in the art should make insubstantial modifications and adaptations to the embodiments of the present invention in light of the above teachings and remain within the scope of the invention.
Example 1 method for separating and determining contents of two drugs and bacteriostatic agent in naftifine ketoconazole cream
The instrument comprises the following steps: SHIMADZU LC-20A (Shimadzu Japan)
A chromatographic column: agilent XDB-C18150 mm X4.6 mm, 5 μm
Mobile phase A: 0.05% tetrabutylammonium bromide
Mobile phase B: methanol-acetonitrile (30:70)
Flow rate: 1.0ml/min
A detector: UV (ultraviolet) light
Detection wavelength: 235nm
Sample introduction volume: 20 μ l
A chromatographic workstation: labsolution
Linear gradient elution procedure:
TABLE 1 Linear gradient elution procedure
Figure BDA0001455376840000051
Sample preparation: taking 0.5g of the product, precisely weighing, placing in a 50ml measuring flask, adding 30ml of 80% methanol, heating in a water bath at 60 ℃, shaking to melt and disperse the paste uniformly, continuing to extract for 5 minutes, taking out, placing in an ice water bath for cooling for more than 30 minutes, taking out, cooling to room temperature, adding 80% methanol to dilute to a scale, shaking uniformly, filtering, precisely measuring 20 mu l of subsequent filtrate, injecting into a liquid chromatograph, and recording a chromatogram; respectively taking a proper amount of potassium sorbate, naftifine hydrochloride and ketoconazole reference substances, precisely weighing, placing in a brown volumetric flask, adding 80% methanol for dissolving, quantitatively diluting and diluting to prepare solutions of 20 mu g of potassium sorbate, 100 mu g of naftifine hydrochloride and 25 mu g of ketoconazole in each 1ml, shaking up, measuring by the same method, and calculating by peak area according to an external standard method to obtain the product.
Example 2 results of sample measurement
The content of lots of naftifine ketoconazole cream was measured as in example 1.
TABLE 2 detection results of naftifine ketoconazole cream content
Batch number Potassium sorbate% Naftifine hydrochloride, based on Ketoconazole,% of
20160401 0.2 100.5 100.6
20160402 0.18 99.9 100.3
20160403 0.19 98.9 99.9
Example 3 methodological verification, separation and determination of the content of two drugs in the naftifine ketoconazole cream
1. Blank matrix interference test
Taking 0.5g each of naftifine ketoconazole cream and blank matrix, processing and dissolving according to the content method, injecting 20 mu l of sample, and recording chromatogram (figure 1 and figure 2).
And (3) test results: the blank matrix does not interfere with the detection of the two drugs and the bacteriostatic agent.
2. Linear relation
Precisely weighing naftifine hydrochloride reference substance about 100mg, ketoconazole reference substance about 25mg and potassium sorbate reference substance 20mg, placing the reference substances into a 100ml volumetric flask, adding 80% methanol for dissolving and diluting to a scale to be used as a stock solution, precisely weighing 3.0, 4.0, 5.0, 6.0 and 7.0ml of the stock solution respectively, placing the stock solutions into 50ml volumetric flasks respectively, diluting to the scale (equivalent to the concentration of the test sample of 60-140%) with 80% methanol, shaking up, sequentially sampling 20 mul, recording peak areas respectively, and performing linear regression.
TABLE 3 Linear relationship of content detection method
Component name Linear equation of equations Correlation coefficient
Potassium sorbate y=67761x-3771 R=0.99999
Naftifine hydrochloride y=73484x+3633.9 R=0.99999
Ketoconazole y=42900x-4427.7 R=0.99999
And (3) test results: the concentration of each component in the range equivalent to 60-140% of the concentration of the solution of the content detection test sample shows a good linear relation with the peak area.
5. Precision degree
Preparing 9 samples according to a content method, and detecting the concentration of the sample solution by content detection, namely 80%, 100% and 120% respectively.
TABLE 4 method for determining the precision of the content
Figure BDA0001455376840000071
And (3) test results: the RSD of each component is less than 2 percent, which meets the requirement of high performance liquid chromatography for content determination.
6. Recovery test
A mixed solution containing about 0.2mg of potassium sorbate, 0.25mg of ketoconazole and 1mg of naftifine hydrochloride per 1ml was prepared with 80% methanol. Precisely measuring 3 parts of 4.0ml, 5.0ml and 6.0ml, respectively, adding into 0.5g blank matrix, stirring, preparing into test solution according to content method, measuring content of each part according to method, and calculating recovery rate.
TABLE 5 content detection method recovery
Figure BDA0001455376840000072
And (3) test results: the average recovery rate of the potassium sorbate is measured to be 99.7 percent and the RSD is 1.3 percent within the range of 80 to 120 percent; the average recovery rate of naftifine hydrochloride is 99.5 percent, and the RSD is 0.6 percent; the average recovery of ketoconazole was 99.2% and RSD was 0.5%. The method is proved to have good accuracy and meet the requirement of high performance liquid chromatography on content determination.
Finally, the above embodiments are only for illustrating the technical solutions of the present invention and not for limiting, although the present invention has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions may be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all of them should be covered in the claims of the present invention.

Claims (4)

  1. The method for separating and determining the two drugs and the bacteriostatic agent in the naftifine ketoconazole cream by the HPLC method is characterized in that octadecylsilane chemically bonded silica is used as a filler in a chromatographic column adopted by the method, mobile phase A and mobile phase B are adopted for gradient elution, and the gradient elution enters a detector for detection; the two medicines are naftifine hydrochloride and ketoconazole, and the bacteriostatic agent is potassium sorbate;
    the mobile phase A is 0.05 percent tetrabutylammonium bromide solution; the mobile phase B is a methanol and acetonitrile solution with the volume ratio of 30: 70;
    the gradient elution was set as follows:
    Figure FDA0002492655610000011
    the flow rate of the mobile phase for elution is 0.9-1.1 ml/min; the detection wavelength of the detector is 220-260 nm.
  2. 2. The method of claim 1, wherein the chromatography column has a size of 4.6 x 150mm, 5 μm.
  3. 3. The method according to any one of claims 1-2, comprising in particular the steps of:
    1) preparing a blank solution: taking a solvent as a blank solution;
    2) preparing a test sample solution: dissolving a sample to be tested in a solvent to obtain a sample solution;
    3) preparing a reference solution: dissolving naftifine hydrochloride reference substance, ketoconazole reference substance and potassium sorbate reference substance in a solvent for dilution to prepare a reference substance solution;
    4) respectively taking the blank solution in the step 1), the step 2) the sample to be tested and the step 3) the reference solution is injected, carrying out high performance liquid chromatography analysis, recording a chromatogram, determining the retention time of two drugs and the bacteriostatic agent in the naftifine ketoconazole cream, and calculating the contents of the two drugs and the bacteriostatic agent in the naftifine ketoconazole cream in the sample to be tested by a peak area according to an external standard method.
  4. 4. The method according to claim 3, wherein the solvent in steps 1) to 3) is methanol with a volume fraction of 80%.
CN201711064092.XA 2017-11-02 2017-11-02 Method for separating and determining two drugs and bacteriostatic agent in naftifine ketoconazole cream by HPLC method Active CN107860839B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201711064092.XA CN107860839B (en) 2017-11-02 2017-11-02 Method for separating and determining two drugs and bacteriostatic agent in naftifine ketoconazole cream by HPLC method

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201711064092.XA CN107860839B (en) 2017-11-02 2017-11-02 Method for separating and determining two drugs and bacteriostatic agent in naftifine ketoconazole cream by HPLC method

Publications (2)

Publication Number Publication Date
CN107860839A CN107860839A (en) 2018-03-30
CN107860839B true CN107860839B (en) 2020-08-11

Family

ID=61700521

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201711064092.XA Active CN107860839B (en) 2017-11-02 2017-11-02 Method for separating and determining two drugs and bacteriostatic agent in naftifine ketoconazole cream by HPLC method

Country Status (1)

Country Link
CN (1) CN107860839B (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06145194A (en) * 1992-11-06 1994-05-24 Mercian Corp New antibiotic substance mer-nf8054a and mer-nf8054x and their production
CN101762659A (en) * 2010-01-05 2010-06-30 广东省汕头市药品检验所 Quick screening method for illegally-added ketoconazole in scurf removing shampoo cosmetics
WO2012037000A1 (en) * 2010-09-15 2012-03-22 Norac, Pharma Benzoyl peroxide composition, methods of making same, and pharmaceutical or cosmetic formulations comprising same, and uses thereof
CN106018614A (en) * 2016-06-23 2016-10-12 湖北人福成田药业有限公司 Method for detecting related substances in ketoconazole sample and method for preparing ketoconazole preparation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06145194A (en) * 1992-11-06 1994-05-24 Mercian Corp New antibiotic substance mer-nf8054a and mer-nf8054x and their production
CN101762659A (en) * 2010-01-05 2010-06-30 广东省汕头市药品检验所 Quick screening method for illegally-added ketoconazole in scurf removing shampoo cosmetics
WO2012037000A1 (en) * 2010-09-15 2012-03-22 Norac, Pharma Benzoyl peroxide composition, methods of making same, and pharmaceutical or cosmetic formulations comprising same, and uses thereof
CN106018614A (en) * 2016-06-23 2016-10-12 湖北人福成田药业有限公司 Method for detecting related substances in ketoconazole sample and method for preparing ketoconazole preparation

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
复方盐酸萘替芬乳膏对离体豚鼠皮肤的透皮吸收研究;袁晓琼等;《中国药房》;20081231;第19卷(第1期);28-30 *
高效液相色谱法测定不同基质的食品中防腐剂含量;刘晓慧等;《理化检验(化学分册)》;20170430;第53卷(第4期);447-450 *

Also Published As

Publication number Publication date
CN107860839A (en) 2018-03-30

Similar Documents

Publication Publication Date Title
CN109725073B (en) Separation and detection method of acetylcysteine enantiomer
CN111443151B (en) Method for detecting content of trace cysteine in compound amino acid injection
CN109060973B (en) Method for detecting ethylenediamine in lipoic acid injection
CN110824093A (en) Method for detecting brivaracetam and related substances thereof
Zhang et al. Sensitive determination of melamine leached from tableware by reversed phase high-performance liquid chromatography using 10-methyl-acridone-2-sulfonyl chloride as a pre-column fluorescent labeling reagent
CN110849980A (en) Method for detecting content of enantiomer in isopropyl L-alanine
CN101216468B (en) 2-methoxymethyl-4-aminophenol and its impurity highly effective liquid phase chromatography analytical method
CN107860839B (en) Method for separating and determining two drugs and bacteriostatic agent in naftifine ketoconazole cream by HPLC method
CN116642970A (en) Sample pretreatment method for simultaneously detecting 6 drug concentrations in blood
CN113358773B (en) Reversed phase liquid chromatography method for detecting atomoxetine hydrochloride enantiomer
CN114324642B (en) Method for determining dextromethorphan hydrobromide related substances
CN103175930B (en) A kind of HPLC analytical method measuring sodium sulphite content
CN112986450B (en) Method for detecting impurity A in ipratropium bromide
CN111044640B (en) Method for determining content of gamma-aminobutyric acid in feed additive by GC (gas chromatography) method
CN111351886B (en) Method for determining impurity and main medicine content in phenol sulfoethylamine medicine
CN110412164B (en) Method for detecting related substances of mexiletine hydrochloride
CN108226340B (en) Method for separating and measuring diflucortolone and 6 beta diflucortolone and 16 beta diflucortolone thereof
CN112748202B (en) Analytical method for measuring degradation products of oral solution containing methylparaben by HPLC (high Performance liquid chromatography)
CN117368378B (en) Method for detecting content of auxiliary materials in levocarnitine oral solution
CN112630347B (en) HPLC analysis method for 4-nitrophenethylamine
CN112433017B (en) Method for detecting specific metabolites of spermidine lycium barbarum
CN108872413B (en) Method for detecting enantiomer content in (S, S) -2, 8-diazabicyclo [4,3,0] nonane
CN112986405A (en) Ultra-high performance liquid phase fingerprint detection method for traditional Chinese medicine injection
CN116223637A (en) Ion chromatography determination method for sugar alcohol in wine
CN115128188A (en) Detection method for nitrite in metronidazole and metronidazole tablets

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant