盐酸西尼地平与琥珀酸美托洛尔联用剂型的hplc法研究与验证

Dhwani K. Desai, Nirmal Vashi, H. Dalvadi, Shuchi H. Desai, M. Hinge
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引用次数: 11

摘要

前言与目的:建立并验证了高效液相色谱法同时测定西尼地平和琥珀酸美托洛尔联用片剂剂型的方法。方法:采用高效液相色谱法,以硅胶G60 F254薄层板为固定相,以甲苯:氯甲烷:甲醇:冰醋酸(45:25:25:5 v/v/v/v /v)为流动相,分离CIL和METO。CIL和METO在231 nm处定量。该方法已根据国际协调会议进行了验证。结果与讨论:CIL和METO在Rf值分别为0.70±0.01和0.34±0.005时获得两个分离良好的尖峰。hplc法对CIL和METO的线性范围分别为100 ~ 500 ng/spot和500 ~ 2500 ng/spot。结论:方法验证准确、专属性强、精密度高。该方法成功地应用于复方片剂中CIL和METO的测定。关键词:西尼地平,琥珀酸美托洛尔,HPTLC,片剂,同时估计,方法验证
本文章由计算机程序翻译,如有差异,请以英文原文为准。
HPTLC Method Development and Validation of Cilnidipine and Metoprolol Succinate in Combined Dosage Form
Introduction and Objectives: The present work involves development and validation of HPTLC method for simultaneous estimation of Cilnidipine and Metoprolol Succinate in their combined tablet dosage form. Method: In HPTLC method, Silica Gel G60 F254 TLC plate as the stationary phase and a mobile phase of Toluene: Chloroform: Methanol: Glacial acetic acid (45: 25: 25: 5 v/v/v/v) was used to resolve CIL and METO. CIL and METO were quantified at 231 nm. The proposed method weas validated according to International Conference on Harmonization. Result and Discussion: Two well-separated and sharp peak for CIL and METO were obtained at Rf values of 0.70 ± 0.01 and 0.34 ± 0.005 respectively. The linearity range obtained for HPTLC method were 100-500 ng/spot and 500-2500 ng/spot for CIL and METO respectively. Conclusion: Method validation was found to be accurate, specific and precise.The developed method was successfully applied for estimation of CIL and METO in combined tablet formulation. Key words: Cilnidipine, Metoprolol succinate, HPTLC, Tablets, Simultaneous estimation, Method validation.
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