ANALYTICAL METHOD DEVELOPMENT AND VALIDATIONs FOR SIMULTANEOUS ESTIMATION OF ANTIHYPERTENSIVE DRUGS

Harshith Kumar R.*, Jinesh B. Nagavi, Bindhyashree K. M., Sahana K. M. and K. Hanumanthachar Joshi

ABSTRACT

The present work involves development and validation of RP-UPLC methods for simultaneous estimation of Telmisartan and Azelnidipine. In UPLC method, C 18 column (250mm x 4.6mm, 5μm) column was used as stationary phase and Mobile phase A consist of (0.1% formic acid in water as an aqueous phase) and Mobile Phase B consist of (acetonitrile as an organic modifier). The flow rate was 0.8ml/min and both drugs were quantified at 260 nm. The retention time for Telmisartan and Azelnidipine was found to be 5.950 min and 7.293min respectively. The linearity range obtained for RP-UPLC method was 10-160 μg/ml and 5-80 μg/ml for Telmisartan and Azelnidipine respectively. The method was validated according to the guidelines of International Conference on Harmonization (ICH).

Keywords: Telmisartan, Azelnidipine, Validation, UPLC.