CN113466365A - 一种用hplc检测氧氟沙星片中有关杂质的方法 - Google Patents
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Abstract
本发明公开了一种用HPLC检测氧氟沙星片中有关杂质的方法,包括:制备氧氟沙星片的供试品溶液,所述供试品溶液的溶剂为体积比为79:21的0.05mol/L枸橼酸溶液和乙腈的混合物,且该混合物用三乙胺调PH直至4.0;采用主成分自身对照法检测氧氟沙星片中有关杂质;其中,HPLC的色谱条件如下:固定相:十八烷基硅烷键合硅胶,流动相:供试品溶液的溶剂,流速:0.8~1.5ml/min,柱温:38~42℃,检测波长:290~295nm。该方法有效改善了0.1mol/L盐酸所带来的HPLC谱图中的溶剂峰较乱且占用保留时间较长的问题,从而能够更准确的检测氧氟沙星片中的有关物质是否合格。
Description
技术领域
本发明涉及氧氟沙星制剂领域,特别涉及一种用HPLC检测氧氟沙星片中有关杂质的方法。
背景技术
在药物分析中所称的“有关物质(related substances)”是指特定药物中不是主要组成物,但与其相关的物质。由于一种药品从合成原料药到制备有关的制剂,再经贮藏、运输、使用,要经历一段较为复杂和漫长的过程,在此期间,每一过程都有可能产生有关的物质。有关物质对于药物制剂的疗效甚至安全性都会产生影响,因此,对于药品中有关物质的检测,对于药品的质量控制而言是必不可少的。
氧氟沙星(Ofloxacin),又名氟嗪酸,是1982年由日本第一制药株式会社与群马大学联合研制成功的,属于第三代氟喹诺酮类药物,具有抗菌谱广、抗菌作用强的特点,现已在国际上广泛应用于临床,主要用于呼吸***、胃肠道、泌尿道、口腔科及妇科等领域的感染症状。
氧氟沙星片是氧氟沙星的一种常见剂型。在中国药典2015版第二部中,采用高效液相色谱(HPLC)对氧氟沙星片中有关物质进行检测,其中,采用0.1mol/L的盐酸作为溶剂溶解氧氟沙星片来制备供试品溶液。本申请的发明人发现,0.1mol/L盐酸溶液制备供试品溶液时,HPLC谱图中的溶剂峰较乱且占用保留时间较长,不利于有关物质的测定。
发明内容
为解决现有技术中的问题,本申请实施例提供一种用HPLC检测氧氟沙星片中有关杂质的方法。
本申请的技术方案如下:
本申请提供了一种用HPLC检测氧氟沙星片中有关杂质的方法,包括:
制备氧氟沙星片的供试品溶液,所述供试品溶液的溶剂为体积比为79:21的0.05mol/L枸橼酸溶液和乙腈的混合物,且该混合物用三乙胺调PH直至4.0;
采用主成分自身对照法检测氧氟沙星片中有关杂质;
其中,HPLC的色谱条件如下:
固定相:十八烷基硅烷键合硅胶,
流动相:供试品溶液的溶剂,
流速:0.8~1.5ml/min,
柱温:38~42℃,
检测波长:290~295nm。
在本申请的一些实施方式中,所述主成分自身对照法包括以下步骤:
量取所述供试品溶液,并用流动相制成氧氟沙星的对照溶液;
将所述供试品溶液和对照溶液分别注入高效液相色谱仪中,获得供试品溶液和对照溶液各自的色谱图,
将供试品溶液的色谱图和对照溶液的色谱图进行比较,从而确定所述氧氟沙星片中的有关物质的含量是否合格。
在本申请的一些实施方式中,在供试品溶液的色谱图中显示杂质峰的情况下,将供试品溶液的色谱图中各杂质峰面积的总和与对照溶液的色谱图中的氧氟沙星特征峰的峰面积进行比较,在所述各杂质峰面积的总和不大于所述氧氟沙星特征峰的峰面积的情况下,确定所述氧氟沙星片中的有关物质的含量合格。
在本申请的一些实施方式中,所述供试品溶液中,氧氟沙星片的浓度为0.25mg/ml。
在本申请的一些实施方式中,所述氧氟沙星的对照溶液中,氧氟沙星的浓度为0.0025mg/ml。
在本申请的一些实施方式中,HPLC的色谱条件中的流速为1.0ml/min。
在本申请的一些实施方式中,HPLC的色谱条件中的柱温为40℃。
在本申请的一些实施方式中,HPLC的色谱条件中的检测波长为293nm。
在本申请的一些实施方式中,HPLC的色谱条件还包括进样量20μl。
本申请的技术方案,在采用HPLC检测氧氟沙星片中有关杂质的过程中,将供试品溶液的传统溶剂0.1mol/L盐酸,更换为用三乙胺调PH直至4.0的体积比为79:21的0.05mol/L枸橼酸溶液和乙腈的混合物,有效改善了0.1mol/L盐酸所带来的HPLC谱图中的溶剂峰较乱且占用保留时间较长的问题,从而能够更准确的检测氧氟沙星片中的有关物质是否合格,即是否符合中国药典的要求。
附图说明
图1为0.1mol/L盐酸的HPLC图谱;
图2为用三乙胺调PH直至4.0的体积比为79:21的0.05mol/L枸橼酸溶液和乙腈的混合物的HPLC图谱;
图3A为实施例2中制备的氧氟沙星片的供试品溶液的HPLC图谱;
图3B为实施例2中制备的氧氟沙星片的供试品溶液的HPLC图谱。
具体实施方式
为使本申请的目的、技术方案和优点更加清楚,下面通过具体实施例将对本申请的技术方案进行清楚、完整地描述。
需要说明的是,以下实施例中未注明具体条件者,按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者,均为可以通过市售购买获得的常规产品。
实施例1 供试品溶液溶剂的比较
将0.1mol/L盐酸以及用三乙胺调PH直至4.0的体积比为79:21的0.05mol/L枸橼酸溶液和乙腈的混合物20μl分别注入到高效液相色谱仪中,按照以下的色谱条件进行检测。
色谱条件:
固定相:十八烷基硅烷键合硅胶,
流动相:0.05mol/L枸橼酸溶液-乙腈(79:21)用三乙胺调PH直至4.0,
流速:1.0ml/min,
柱温:40℃,
检测波长:293nm。
图1为0.1mol/L盐酸的HPLC图谱。图2为用三乙胺调PH直至4.0的体积比为79:21的0.05mol/L枸橼酸溶液和乙腈的混合物的HPLC图谱。比较图1和图2可以看出,用三乙胺调PH直至4.0的体积比为79:21的0.05mol/L枸橼酸溶液和乙腈的混合物作为溶剂,可以有效改善0.1mol/L盐酸所带来的HPLC谱图中的溶剂峰较乱且占用保留时间较长的问题,从而能够更准确的检测氧氟沙星片中的有关物质是否合格。
实施例2 氧氟沙星片中有关杂质的检测
对自制的氧氟沙星片样品中的有关杂质进行检测。检测过程具体如下:
(1)精密称取氧氟沙星片样品粉适量,加溶剂溶解、过滤,取滤液制成每1ml约含氧氟沙星0.25mg溶液,作为供试品溶液;该溶剂为用三乙胺调节PH直至4.0的体积比为79:21的0.05mol/L枸橼酸溶液和乙腈的混合物。
(2)精密量取供试品溶液适量,用与步骤(1)相同的溶剂制成每1ml约含氧氟沙星0.0025mg的溶液,作为对照溶液。
(3)量取供试品溶液20μl注入液相色谱仪,记录色谱图至主成分峰保留时间的2倍,所获得的高效液相色谱图如图3A所示。
(4)量取对照溶液20μl注入液相色谱仪,记录色谱图至主成分峰保留时间的2倍,所获得的高效液相色谱图如图3B所示。
经谱图分析可以确定,供试品溶液的色谱图中各杂质峰面积的总和小于对照溶液的色谱图中的氧氟沙星特征峰(主峰)的峰面积,由此确定该氧氟沙星片样品中的有关物质的含量合格;
其中,色谱条件如下:
固定相:十八烷基硅烷键合硅胶,
流动相:0.05mol/L枸橼酸溶液-乙腈(79:21)用三乙胺调PH直至4.0,
流速:1.0ml/min,
柱温:40℃,
检测波长:293nm。
以上所述仅为本申请的优选实施例而已,并不用于限制本申请,对于本领域中的技术人员来说,本申请可以有各种修改和变化。凡在本申请的主旨和原则之内所作的任何修改、等同替换、改进等,均应包含在本申请的保护范围之内。
Claims (9)
1.一种用HPLC检测氧氟沙星片中有关杂质的方法,其特征在于,包括:
制备氧氟沙星片的供试品溶液,所述供试品溶液的溶剂为体积比为79:21的0.05mol/L枸橼酸溶液和乙腈的混合物,且该混合物用三乙胺调PH直至4.0;
采用主成分自身对照法检测氧氟沙星片中有关杂质;
其中,HPLC的色谱条件如下:
固定相:十八烷基硅烷键合硅胶,
流动相:供试品溶液的溶剂,
流速:0.8~1.5ml/min,
柱温:38~42℃,
检测波长:290~295nm。
2.根据权利要求1所述的方法,其特征在于,所述主成分自身对照法包括以下步骤:
量取所述供试品溶液,并用流动相制成氧氟沙星的对照溶液;
将所述供试品溶液和对照溶液分别注入高效液相色谱仪中,获得供试品溶液和对照溶液各自的色谱图,
将供试品溶液的色谱图和对照溶液的色谱图进行比较,从而确定所述氧氟沙星片中的有关物质的含量是否合格。
3.根据权利要求2所述的方法,其特征在于,在供试品溶液的色谱图中显示杂质峰的情况下,将供试品溶液的色谱图中各杂质峰面积的总和与对照溶液的色谱图中的氧氟沙星特征峰的峰面积进行比较,在所述各杂质峰面积的总和不大于所述氧氟沙星特征峰的峰面积的情况下,确定所述氧氟沙星片中的有关物质的含量合格。
4.根据权利要求1-3中任一项所述的方法,其特征在于,所述供试品溶液中,氧氟沙星片的浓度为0.25mg/ml。
5.根据权利要求2或3所述的方法,其特征在于,所述氧氟沙星的对照溶液中,氧氟沙星的浓度为0.0025mg/ml。
6.根据权利要求1-3中任一项所述的方法,其特征在于,HPLC的色谱条件中的流速为1.0ml/min。
7.根据权利要求1-3中任一项所述的方法,其特征在于,HPLC的色谱条件中的柱温为40℃。
8.根据权利要求1-3中任一项所述的方法,其特征在于,HPLC的色谱条件中的检测波长为293nm。
9.根据权利要求1-3中任一项所述的方法,其特征在于,HPLC的色谱条件还包括进样量20μl。
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JPH01305091A (ja) * | 1988-06-01 | 1989-12-08 | Daicel Chem Ind Ltd | オフロキサシンのエステル類の光学分割方法 |
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JPH01305091A (ja) * | 1988-06-01 | 1989-12-08 | Daicel Chem Ind Ltd | オフロキサシンのエステル類の光学分割方法 |
CN111458436A (zh) * | 2020-04-18 | 2020-07-28 | 山东齐都药业有限公司 | 测定左氧氟沙星原料及制剂中光降解杂质的方法 |
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