Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF CELECOXIB AND AMLODIPINE BESYLATE IN PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

Sushma N.*, A. Satishkumar Shetty, Manzoor Ahmed, Anil Kumar S. M.

ABSTRACT

A reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous estimation of Celecoxib and Amlodipine Besylate in pure and marketed formulations. Separation was carried out using column Enable C18 (250 mm x 4.6mm x 5μm particle size) in isocratic mode using mobile phase composition Acetonitrile and 0.1% OPA (pH 3.5) in the ratio 70:30 v/v and UV detection at 215 nm. The compounds were eluted at a flow rate of 0.8 ml/ min. The average retention times for Celecoxib and Amlodipine Besylate were 7.040 and 2.317 min, respectively. The method was validated according to the ICH guidelines. The % RSD of all validation parameters found to be less than 2% indicating high degree of accuracy and precision of the proposed HPLC method. The method was linear over the concentration of 10-50 μg/ml and 20- 100 μg/ml for Celecoxib and Amlodipine Besylate respectively. The LOD and LOQ of Celecoxib were found to be 0.079μg/ml and 0.239μg/ml and of Amlodipine Besylate were found to be 0.678 μg/ml and 2.054 μg/ml.

Keywords: Celecoxib, Amlodipine Besylate, RP-HPLC, Validation and ICH guidelines.