Abstract

A NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF AMLODIPINE AND CELECOXIB IN PURE FORM AND MARKETED COMBINED PHARMACEUTICAL DOSAGE FORM

Dorepally Anusha* and A. Yasodha

ABSTRACT

A new, simple, analytical, accurate, economical, robust, rapid and precise reverse phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Amlodipine and Celecoxib in its pure form as well as in marketed pharmaceutical dosage form. Chromatography was carried out on a Phenomenex Luna C18, 150 mm x 4.6 mm and 5μm column using a mixture of Phosphate buffer (0.02M) pH-3.8: Methanol: Acetonitrile were taken in the proportion of 60:20:20% v/v/v (pH-3.4) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 260 nm. The retention times of the Amlodipine and Celecoxib was found to be 2.324min and 4.314min ±0.02min respectively. The developed method produce linear responses in the concentration range of 12-36μg/ml & 13-39μg/ml of Amlodipine and Celecoxib respectively. The method precision for the determination of assay was below 2.0 %RSD. The method is useful in the quality control of bulk and pharmaceutical Dosage forms.

Keywords: Amlodipine and Celecoxib, RP-HPLC, Method Development, Validation, Accuracy.