雷米普利、阿斯匹林、辛伐他汀原料药和制剂同时测定稳定性指示RP-HPLC法的建立与验证

Mohan Gandhi Bonthu
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引用次数: 6

摘要

目的:建立一种简便、快速、精确、选择性和准确的反相高效液相色谱法同时测定某剂型中雷米普利(RAM)、阿司匹林(ASP)和辛伐他汀(SIM)的含量。材料与方法:采用shishhedo C 18, 250×4.6mm, 5微米柱,流动相为0.5%邻位磷酸:ACN:甲醇(20:10:70 v/v),流速为1ml/min,紫外检测波长为226nm。结果:雷米普利(RAM)、阿司匹林(ASP)和辛伐他汀(SIM)的滞留时间分别为2.1、2.7和9.6 min。雷米普利(RAM)、阿司匹林(ASP)和辛伐他汀(SIM)分别在5 ~ 15μg/ml、50 ~ 150μg/ml、20 ~ 60μg/ml呈线性关系。对方法的线性度、回收率、检出限、定量限、准确度和精密度进行了统计验证。分别在酸性、碱性、氧化性、光稳定性和热降解条件下对药物进行了单独和混合的应力测试,降解产物从分析峰上得到了很好的分离。结论:该方法的准确度、精密度、线性、检出限和定量限均得到了验证。关键词:雷米普利,阿司匹林,辛伐他汀,反相高效液相色谱
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Ramipril, Aspirin and Simvastatin in Bulk and Pharmaceutical Dosage Form
Objective: The objective of present work was to develop and validate a simple, fast, precise, selective and accurate RP-HPLC method for the simultaneous determination Ramipril(RAM), Aspirin (ASP) and Simvastatin (SIM) in a Pharmaceutical dosage form. Materials and Methods: The separation of these three drugs was achieved on a SHISHEDO C 18 , 250×4.6mm, 5 micron size column with a mobile phase consisting of 0.5% Ortho phosphoric acid :ACN:Methanol(20:10:70 v/v)  at a flow rate of 1ml/min and UV detection at 226nm. Results: The retention times were observed to be 2.1, 2.7 and 9.6 minutes for Ramipril (RAM), Aspirin (ASP) and Simvastatin (SIM) respectively. Linearity was found to be 5-15μg/ml, 50-150μg/ml, 20-60μg/ml for Ramipril(RAM), Aspirin(ASP)and Simvastatin(SIM) respectively. The method was statistically validated for linearity, recovery, limit of detection, limit of quantification, accuracy and precision. The stress testing of the drugs individually and their mixture is carried out under acidic, alkaline, oxidation, photo-stability and thermal degradation conditions and its degradation products are well resolved from the analyte peaks Conclusion: This method was successfully validated for accuracy, precision, and linearity, limit of detection and limit of quantification. Keywords: Ramipril(RAM), Aspirin (ASP) Simvastatin (SIM)reverse phase high performance liquid chromatography.
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