CN113466365A - Method for detecting related impurities in ofloxacin tablets by using HPLC (high performance liquid chromatography) - Google Patents
Method for detecting related impurities in ofloxacin tablets by using HPLC (high performance liquid chromatography) Download PDFInfo
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- CN113466365A CN113466365A CN202110697790.3A CN202110697790A CN113466365A CN 113466365 A CN113466365 A CN 113466365A CN 202110697790 A CN202110697790 A CN 202110697790A CN 113466365 A CN113466365 A CN 113466365A
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- GSDSWSVVBLHKDQ-UHFFFAOYSA-N 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid Chemical compound FC1=CC(C(C(C(O)=O)=C2)=O)=C3N2C(C)COC3=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-UHFFFAOYSA-N 0.000 title claims abstract description 42
- 229960001699 ofloxacin Drugs 0.000 title claims abstract description 42
- 238000004128 high performance liquid chromatography Methods 0.000 title claims abstract description 35
- 238000000034 method Methods 0.000 title claims abstract description 25
- 239000012535 impurity Substances 0.000 title claims abstract description 20
- ZMANZCXQSJIPKH-UHFFFAOYSA-N Triethylamine Chemical compound CCN(CC)CC ZMANZCXQSJIPKH-UHFFFAOYSA-N 0.000 claims abstract description 33
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 33
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims abstract description 29
- 239000012085 test solution Substances 0.000 claims abstract description 29
- 239000000243 solution Substances 0.000 claims abstract description 26
- 239000002904 solvent Substances 0.000 claims abstract description 17
- 239000000126 substance Substances 0.000 claims abstract description 16
- 239000000203 mixture Substances 0.000 claims abstract description 14
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 6
- 230000005526 G1 to G0 transition Effects 0.000 claims abstract description 5
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 claims abstract description 5
- 238000001514 detection method Methods 0.000 claims description 10
- 239000007788 liquid Substances 0.000 claims description 7
- BLRPTPMANUNPDV-UHFFFAOYSA-N Silane Chemical compound [SiH4] BLRPTPMANUNPDV-UHFFFAOYSA-N 0.000 claims description 4
- 239000012088 reference solution Substances 0.000 claims description 4
- 229910000077 silane Inorganic materials 0.000 claims description 4
- 239000000741 silica gel Substances 0.000 claims description 4
- 229910002027 silica gel Inorganic materials 0.000 claims description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 abstract description 16
- 230000014759 maintenance of location Effects 0.000 abstract description 6
- 239000000377 silicon dioxide Substances 0.000 abstract 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 239000000523 sample Substances 0.000 description 4
- 229940079593 drug Drugs 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 239000012488 sample solution Substances 0.000 description 3
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229940088679 drug related substance Drugs 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 229940124307 fluoroquinolone Drugs 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 238000005220 pharmaceutical analysis Methods 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 210000001635 urinary tract Anatomy 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
- G01N30/14—Preparation by elimination of some components
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/62—Detectors specially adapted therefor
- G01N30/74—Optical detectors
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/86—Signal analysis
- G01N30/8624—Detection of slopes or peaks; baseline correction
- G01N30/8631—Peaks
- G01N30/8634—Peak quality criteria
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
- G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
- G01N2030/8872—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample impurities
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Abstract
The invention discloses a method for detecting related impurities in ofloxacin tablets by using HPLC (high performance liquid chromatography), which comprises the following steps: preparing a test solution of the oxyfluorsaxate tablets, wherein the solvent of the test solution is a mixture of 0.05mol/L citric acid solution and acetonitrile in a volume ratio of 79:21, and the pH of the mixture is adjusted to 4.0 by triethylamine; detecting related impurities in the ofloxacin tablets by adopting a main component self-contrast method; wherein, chromatographic conditions of HPLC are as follows: stationary phase: octadecylsilane chemically bonded silica, mobile phase: solvent of test solution, flow rate: 0.8-1.5 ml/min, column temperature: and (3) detecting the wavelength at 38-42 ℃: 290-295 nm. The method effectively solves the problems of disordered solvent peaks and long retention time occupation in an HPLC spectrogram caused by 0.1mol/L hydrochloric acid, so that whether related substances in the ofloxacin tablets are qualified or not can be more accurately detected.
Description
Technical Field
The invention relates to the field of ofloxacin preparations, in particular to a method for detecting related impurities in ofloxacin tablets by using HPLC.
Background
In pharmaceutical analysis, the term "related substances" refers to substances related to a specific drug, which are not main components of the drug. Since a pharmaceutical product goes through a complicated and lengthy process from the synthesis of the drug substance to the preparation of the relevant preparation, followed by storage, transportation and use, each process may produce the relevant substances. Substances of interest have an influence on the efficacy and even the safety of pharmaceutical preparations, and therefore, the detection of substances of interest in pharmaceutical preparations is essential for the quality control of pharmaceutical preparations.
Ofloxacin (Ofloxacin), also known as Ofloxacin, was successfully developed by the first pharmaceutical company of japan in 1982 in association with the university of mary, belongs to the third-generation fluoroquinolone drugs, has the characteristics of wide antibacterial spectrum and strong antibacterial action, is now widely used in clinical practice internationally, and is mainly used for infectious symptoms in the fields of respiratory systems, gastrointestinal tracts, urinary tracts, stomatology, gynecology and the like.
The ofloxacin tablet is a common dosage form of ofloxacin. In the second part of the chinese pharmacopoeia 2015 edition, High Performance Liquid Chromatography (HPLC) is used to detect the relevant substances in the ofloxacin tablets, wherein 0.1mol/L hydrochloric acid is used as a solvent to dissolve the ofloxacin tablets to prepare a test solution. The inventor of the application finds that when the test solution is prepared by 0.1mol/L hydrochloric acid solution, the solvent peak in an HPLC spectrogram is disordered and occupies a long retention time, so that the determination of related substances is not facilitated.
Disclosure of Invention
In order to solve the problems in the prior art, the embodiment of the application provides a method for detecting related impurities in ofloxacin tablets by using HPLC.
The technical scheme of the application is as follows:
the application provides a method for detecting related impurities in ofloxacin tablets by using HPLC (high performance liquid chromatography), which comprises the following steps:
preparing a test solution of the oxyfluorsaxate tablets, wherein the solvent of the test solution is a mixture of 0.05mol/L citric acid solution and acetonitrile in a volume ratio of 79:21, and the pH of the mixture is adjusted to 4.0 by triethylamine;
detecting related impurities in the ofloxacin tablets by adopting a main component self-contrast method;
wherein, chromatographic conditions of HPLC are as follows:
stationary phase: octadecylsilane chemically bonded silica gel, and a silane,
mobile phase: the solvent of the test solution is selected from the group consisting of,
flow rate: 0.8 to 1.5ml/min,
column temperature: 38-42 ℃,
detection wavelength: 290-295 nm.
In some embodiments of the present application, the principal component self-control method comprises the steps of:
measuring the test solution, and preparing a control solution of ofloxacin by using a mobile phase;
injecting the test solution and the reference solution into a high performance liquid chromatograph respectively to obtain respective chromatograms of the test solution and the reference solution,
and comparing the chromatogram of the test solution with the chromatogram of the control solution to determine whether the content of the related substances in the ofloxacin tablet is qualified.
In some embodiments of the present application, in the case where an impurity peak is shown in a chromatogram of a test solution, the sum of the peak areas of each impurity in the chromatogram of the test solution is compared with the peak area of the characteristic peak of ofloxacin in the chromatogram of a control solution, and in the case where the sum of the peak areas of each impurity is not greater than the peak area of the characteristic peak of ofloxacin, the content of the relevant substance in the ofloxacin tablet is determined to be acceptable.
In some embodiments of the present application, the concentration of the oxafloxacin tablets in the test solution is 0.25 mg/ml.
In some embodiments of the present application, the control solution of ofloxacin has an ofloxacin concentration of 0.0025 mg/ml.
In some embodiments of the present application, the flow rate in chromatographic conditions of HPLC is 1.0 ml/min.
In some embodiments of the present application, the column temperature in the chromatographic conditions of the HPLC is 40 ℃.
In some embodiments of the present application, the detection wavelength in chromatographic conditions of HPLC is 293 nm.
In some embodiments of the present application, the chromatographic conditions of the HPLC further comprise a sample size of 20 μ l.
According to the technical scheme, in the process of detecting related impurities in the ofloxacin tablets by adopting HPLC, 0.1mol/L hydrochloric acid serving as a traditional solvent of a sample solution is replaced by a mixture of 0.05mol/L citric acid solution and acetonitrile with the volume ratio of 79:21, wherein the PH is adjusted to 4.0 by triethylamine, so that the problems of disordered solvent peaks and long retention time occupation in an HPLC spectrogram caused by 0.1mol/L hydrochloric acid are effectively solved, and whether related substances in the ofloxacin tablets are qualified or not can be accurately detected, namely whether the related substances meet the requirements of Chinese pharmacopoeia or not can be accurately detected.
Drawings
FIG. 1 is an HPLC chromatogram of 0.1mol/L hydrochloric acid;
FIG. 2 is an HPLC chromatogram of a mixture of 0.05mol/L citric acid solution and acetonitrile adjusted to pH 4.0 with triethylamine in a volume ratio of 79: 21;
FIG. 3A is an HPLC chromatogram of a test solution of Oxofloxacin tablet prepared in example 2;
fig. 3B is an HPLC chromatogram of the test solution of oxafloxacin tablets prepared in example 2.
Detailed Description
In order to make the objects, technical solutions and advantages of the present application more apparent, the technical solutions of the present application will be clearly and completely described below through specific embodiments.
In the following examples, those not indicated with specific conditions were performed according to conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.
Example 1 comparison of test article solution solvents
Separately, 20. mu.l of a mixture of 0.05mol/L of citric acid solution and acetonitrile adjusted to pH 4.0 with triethylamine in a volume ratio of 79:21 was injected into a high performance liquid chromatograph, and the detection was performed under the following chromatographic conditions.
Chromatographic conditions are as follows:
stationary phase: octadecylsilane chemically bonded silica gel, and a silane,
mobile phase: 0.05mol/L citric acid solution-acetonitrile (79: 21) is adjusted pH to 4.0 by triethylamine,
flow rate: 1.0ml/min of the mixture is added,
column temperature: at a temperature of 40 c,
detection wavelength: 293 nm.
FIG. 1 is an HPLC chromatogram of 0.1mol/L hydrochloric acid. FIG. 2 is an HPLC chromatogram of a mixture of 0.05mol/L citric acid solution and acetonitrile adjusted to pH 4.0 with triethylamine in a volume ratio of 79: 21. Comparing fig. 1 and fig. 2, it can be seen that the mixture of 0.05mol/L citric acid solution and acetonitrile with the volume ratio of 79:21, which is adjusted by triethylamine until the PH is 4.0, is used as a solvent, so that the problems of disordered solvent peaks and long occupied retention time in an HPLC spectrogram caused by 0.1mol/L hydrochloric acid can be effectively solved, and whether related substances in the ofloxacin tablets are qualified or not can be more accurately detected.
Example 2 detection of impurities in Oxafluorosaxing tablets
And detecting related impurities in the self-made oxyfluorsaxate tablet sample. The detection process is as follows:
(1) precisely weighing a proper amount of ofloxacin tablet sample powder, adding a solvent for dissolution, filtering, and preparing filtrate into a solution of about 0.25mg of ofloxacin per 1ml as a test sample solution; the solvent is a mixture of 0.05mol/L citric acid solution and acetonitrile in a volume ratio of 79:21, the pH of which is adjusted by triethylamine until 4.0.
(2) Precisely measuring a proper amount of the test solution, and preparing a solution of about 0.0025mg of ofloxacin per 1ml by using the same solvent as the step (1) to serve as a control solution.
(3) A20. mu.l sample solution was measured and injected into a liquid chromatograph, and the chromatogram was recorded up to 2 times the retention time of the main component peak, and the obtained high performance liquid chromatogram was shown in FIG. 3A.
(4) A20. mu.l volume of the control solution was measured and injected into a liquid chromatograph, and the chromatogram was recorded up to 2 times the retention time of the main component peak, and the obtained high performance liquid chromatogram was shown in FIG. 3B.
The sum of the peak areas of various impurities in the chromatogram of the test solution is smaller than the peak area of an ofloxacin characteristic peak (main peak) in the chromatogram of the control solution, so that the content of related substances in the ofloxacin tablet sample is determined to be qualified;
wherein, the chromatographic conditions are as follows:
stationary phase: octadecylsilane chemically bonded silica gel, and a silane,
mobile phase: 0.05mol/L citric acid solution-acetonitrile (79: 21) is adjusted pH to 4.0 by triethylamine,
flow rate: 1.0ml/min of the mixture is added,
column temperature: at a temperature of 40 c,
detection wavelength: 293 nm.
The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.
Claims (9)
1. A method for detecting related impurities in ofloxacin tablets by using HPLC (high performance liquid chromatography), which is characterized by comprising the following steps:
preparing a test solution of the oxyfluorsaxate tablets, wherein the solvent of the test solution is a mixture of 0.05mol/L citric acid solution and acetonitrile in a volume ratio of 79:21, and the pH of the mixture is adjusted to 4.0 by triethylamine;
detecting related impurities in the ofloxacin tablets by adopting a main component self-contrast method;
wherein, chromatographic conditions of HPLC are as follows:
stationary phase: octadecylsilane chemically bonded silica gel, and a silane,
mobile phase: the solvent of the test solution is selected from the group consisting of,
flow rate: 0.8 to 1.5ml/min,
column temperature: 38-42 ℃,
detection wavelength: 290-295 nm.
2. The method according to claim 1, wherein the principal component self-control method comprises the steps of:
measuring the test solution, and preparing a control solution of ofloxacin by using a mobile phase;
injecting the test solution and the reference solution into a high performance liquid chromatograph respectively to obtain respective chromatograms of the test solution and the reference solution,
and comparing the chromatogram of the test solution with the chromatogram of the control solution to determine whether the content of the related substances in the ofloxacin tablet is qualified.
3. The method according to claim 2, wherein in the case where an impurity peak is shown in the chromatogram of the test solution, the sum of the peak areas of each impurity in the chromatogram of the test solution is compared with the peak area of the characteristic peak of ofloxacin in the chromatogram of the control solution, and in the case where the sum of the peak areas of each impurity is not more than the peak area of the characteristic peak of ofloxacin, the content of the substance of interest in the ofloxacin tablet is determined to be acceptable.
4. The method of any one of claims 1-3, wherein the concentration of the ofloxacin tablet in the test solution is 0.25 mg/ml.
5. The method of claim 2 or 3, wherein the control solution of ofloxacin has an ofloxacin concentration of 0.0025 mg/ml.
6. The method according to any one of claims 1 to 3, wherein the flow rate in the chromatographic conditions of HPLC is 1.0 ml/min.
7. The method according to any one of claims 1 to 3, wherein the column temperature in the chromatographic conditions of HPLC is 40 ℃.
8. The method according to any one of claims 1 to 3, wherein the detection wavelength in the chromatographic conditions of HPLC is 293 nm.
9. The method of any one of claims 1 to 3, wherein the chromatographic conditions of the HPLC further comprise a sample size of 20 μ l.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH01305091A (en) * | 1988-06-01 | 1989-12-08 | Daicel Chem Ind Ltd | Optical resolution of esters of ofloxacin |
| CN111458436A (en) * | 2020-04-18 | 2020-07-28 | 山东齐都药业有限公司 | Method for measuring photodegradation impurities in levofloxacin raw material and preparation |
-
2021
- 2021-06-23 CN CN202110697790.3A patent/CN113466365A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH01305091A (en) * | 1988-06-01 | 1989-12-08 | Daicel Chem Ind Ltd | Optical resolution of esters of ofloxacin |
| CN111458436A (en) * | 2020-04-18 | 2020-07-28 | 山东齐都药业有限公司 | Method for measuring photodegradation impurities in levofloxacin raw material and preparation |
Non-Patent Citations (4)
| Title |
|---|
| BOBBA VENKATESWARA REDDY 等: "STABILITY INDICATING REVERSED-PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR DETERMINATION OF IMPURITIES IN OFLOXACIN TABLET FORMULATIONS", 《ANALYTICAL LETTERS》 * |
| 丁芬: "HPLC法测定乳酸左氧氟沙星片中有关物质", 《黑龙江医药》 * |
| 傅晓航: "高效液相色谱法测定氧氟沙星胶囊中氧氟沙星的含量", 《化学分析计量》 * |
| 景艳萍: "高效液相色谱法测定氧氟沙星滴眼液中氧氟沙星的含量", 《泰山医学院学报》 * |
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