Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CILNIDIPINE AND IRBESARTAN IN PHARMACEUTICAL DOSAGE FORMS

Azra Unnisa*

ABSTRACT

A simple rapid specific accurate and precise reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Cilnidipine and Irbesartan in tablet dosage form. An insertil ODS C18 column having 150X4.6mm internal diameter in isocratic mode with mobile phase containing Acetonitrile: Phosphate buffer [70:30] 70:30% v/v p H 3.0 was used. The flow rate was 1.0ml/min and effluents were monitored at 254nm. The rententiontime of Cilnidpine and Irbesartan was 3.503min and 2.577min respectively. The concentration curves of Cilnidipine and Irbesartan were linear in the concentration range 20μg-100μg and 20μg-100μg Cilnidipine and Irbesartan respectively. The developed method was validated for system suitability, specificity, precision, linearity, accuracy, LOD, LOQ, range ruggedness, solution stability. Recovery of Cinidipine and Irbesartan in formulation was found tobe in the range of 102.5% and 101.0% respectively. Hence conforming the noninterference of the excipient in the formulation. Due to its simplicity rapidness and high precision, the proposed HPLC method may be used for the simultaneous determination of these two drugs in pharmaceutical dosage form.

Keywords: RP-HPLC; Cilnidipine and Irbesartan.