Abstract

METHOD DEVELOPMENT VALIDATION AND DEGRADATION STUDIES OF SIMULTANEOUS ESTIMATION OF CILNIDIPINE AND OLMESARTAN IN PHARMACEUTICAL DOSAGE FORM

A. Sravani Ratnam*, B. Mallikarjuna and V. Ramesh

ABSTRACT

A simple, accurate, precise RP-HPLC method was developed for the simultaneous estimation of the olmesartan and cilnidipine in tablet dosage form. Separation was performed on a ODS column (250 × 4.6mm ID, 5 μm) with phosphate dihydrogen orthophosphate: acetonitrile (26:74A), flow rate of 0.9 ml/ min and UV detection at wavelength 240 nm. Retention time of olmesartan and cilnidipine were found to be 5.898min and 2.256 min respectively. The method was validated in terms of linearity, precision, accuracy, limit of detection, limit of quantitation and robustness as per the International Conference on Harmonisation (ICH) guidelines. Linearity of olmesartan and cilnidipine were in the range of 50-300 μg/mL and 25-150 μg/mL respectively. %RSD of the olmesartan and cilnidipine were and found to be 0.34 and 0.56 respectively. % assay was obtained as 99.53 and 99.84 for olmesartan and cilnidipine respectively. LOD, LOQ values are obtained from regression equations of olmesartan and cilnidipine were 0.95 mcg / ml, 0.33 mcg / ml and 2.88 mcg / ml, 0.97mcg / ml respectively. Regression equation of olmesartan is y = 2722x + 7848.7 and of cilnidipine is y = 62696x + 6132 with regression co-efficient value was 0.998. Degradation products produced as a result of stress studies did not interfere with the detection of olmesartan and cilnidipine and the assay can thus be considered stability indicating. The developed method can be used for routine quality analysis of titled drugs in combination in tablet formulation.

Keywords: Olmsearatan, Cilnidipine, ODS column, RP-HPLC, Validation.