Analytical Method Development and Validation of Hptlc Method for Simultaneous Estimation of Telmisartan and Azelnidipine in Tablet Dosage Form

Research of Gastric Management and Hepatology Pub Date : 2023-02-25 DOI:10.58489/2836-6204/006

Ashwini Dhruv

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Abstract

Background: A specific, accurate, precise, robust and cost effective HPTLC method was developed and validated for quantitative analysis of Telmisartan and Azelnidipine in fixed dose combination. The separation was carried out on pre-coated TLC plates with Silica gel 60 F254 as stationary phase using Chloroform: Ethyl acetate: Methanol (7.5:2:0.5 v/v/v) as developing system followed by densitometry measurement of bands at 280nm. Result: The separation of Telmisartan and Azelnidipine was found to be at the following RF values 0.3 and 0.63 respectively. Calibration curves were found to be linear over the concentration ranges 400-4000ng/band, 80-800ng/band for Telmisartan and Azelnidipine with correlation coefficient 0.9957 and 0.9966 respectively. Accuracy was found between 98.03% - 102% and 98.72% - 102 % for Telmisartan and Azelnidipine respectively. LOD was found to be 1.04% and 1.6% and LOQ was found to be 3.49% and 5.57% for Telmisartan and Azelnidipine respectively Conclusion: The results showed that the proposed HPTLC method is reliable for routine analysis for simultaneous determination of Telmisartan and Azelnidipine without any interference.

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高效液相色谱法同时测定片剂剂型中替米沙坦和阿泽尼地平含量的方法建立与验证

背景:建立了一种特异、准确、精密度高、稳定期高、成本效益好的高效液相色谱法，用于替米沙坦和阿泽尼地平的固定剂量联合定量分析。以硅胶60f254为固定相，氯仿:乙酸乙酯:甲醇(7.5:2:0.5 v/v/v)为示影体系，在280nm处进行谱带密度测定。结果:替米沙坦与阿泽地平分离的RF值分别为0.3和0.63。替米沙坦和阿泽地平在400 ~ 4000ng/波段、80 ~ 800ng/波段范围内均呈线性，相关系数分别为0.9957和0.9966。替米沙坦和阿泽地平的准确率分别为98.03% ~ 102%和98.72% ~ 102%。替米沙坦和阿泽尼地平的LOD分别为1.04%和1.6%，LOQ分别为3.49%和5.57%。结论:建立的高效液相色谱法可用于同时测定替米沙坦和阿泽尼地平的常规分析，无干扰。

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Research of Gastric Management and Hepatology

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