Simultaneous Estimation of Telmisartan and Indapamide in Bulk Drug and Finished products by RP-HPLC method

A simple, sensitive, rapid, precise and cost effective RP-HPLC method for simultaneous determination of Telmisartan (TELMI) and Indapamide (INDP) in bulk drug and finished products was developed and validated as per ICH guideline in terms of Linearity, Selectivity, Precision, Quantitation Limit, Detection Limit, Accuracy and Robustness. The method employed HiQsil C18 column (250 X 4.6 mm, 5μm particle size) as stationary phase, column temperature was maintained at 25°C, mobile phase containing Acetonitrile: 20 mM ammonium acetate buffer maintained at pH 4.5 (60:40 v/v) using 5 M acetic acid, flow rate of 1 ml/min, using UV detection at 240 nm. The system showed good resolution with retention time of approximate 8 mins and 5 mins for TELMI and INDP respectively.

The linear regression analysis data for calibration plot showed good linear relationship over the concentration range of 0.5–60 μg/ml and 0.05–2.2 μg/ml for TELMI and INDP respectively. The results obtained from statistical analysis showed that the method is Linear, Precise, accurate (Accuracy as % recovery by placebo method), robust (Change in mobile phase composition, flow rate and column temperature) and Selective for simultaneous estimation of TELMI and INDP in analyte. The proposed method can be used for simultaneous estimation of TELMI and INDP in bulk drugs and finished products.