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

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.