Abstract

DEVELOPMENT AND VALIDATION OF RP-HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF AZELNIDIPINE AND TELMISARTAN IN TABLETS

Chandappa*, Lalitha N., Mubeen G. and E. Tejaswini

ABSTRACT

Hypertension is recognized as a major risk factor for cardiovascular and renal diseases and represents the leading cause of mortality worldwide. Nearly 75% of hypertensive patients do not achieve adequate control with monotherapy, thus needing combination treatment. Currently, preferred combinations. An angiotensin-receptor blocker and calcium channel blocker. Some patients will also require a triple combination to achieve blood pressure control¹. Recently available combination product in the market is Azelnidipine and Telmisartan fixed dose tablet formulation (Azelikem T-40, Telmiwal-AP, Telma-AZ, Emdip T-40) which are the tablet used for treat the hypertension. RP-HPLC method has been performed on phenomenex BDS C18 column (250 × 4.6 mm, 5μ) using the mixture of Methanol 95% and phosphate buffer (pH 4.5) 5% and with Acetonitrile in the ratio of 90:10 as mobile phase. The flow rate was maintained at 1.5mL/min and analytes were monitored at 243nm. The retention time for Azelnidipine and Telmisartan was found to be 2.185 and 4.756min respectively with resolution more than 3. The peaks obtained were symmetrical with tailing factor less than 2 and theoretical plates more than 2000. The developed method was validated in accordance with ICH (Q2R1) guidelines. The method was found linear in for Azelnidipine and Telmisartan the concentration range of 1-500μg/ml and relative standard deviation of the precision study was less than 2.0%. The assay results was found 103.4 (±2.01) and 106.8 (±1.94) % with mean % Recovery 100.77 and 109.93 for Azelnidipine and Telmisartan respectively.

Keywords: Azelnidipine(AZEL), Telmisartan(TEL), RP-HPLC.