Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION AND ASSAY OF RILPIVIRINE HCL

Nuzhath Fathima*, M. Brahmaiah, P. Raveendra Reddy and G. Abdul Huq

ABSTRACT

Reverse phase stability indicating high performance liquid chromatographic (HPLC) assay method was developed and validated for quantitative determination of Rilpivirine HCl. A reverse phase HPLC method was developed to separate the drug from the degradant products using a inertsil C18 (250x4.6) mm, 5μ column and the mobile phase containing 15 mM potassium dihydrogen phosphate anhydrous and pH adjusted to pH=3.0 with H3PO4 (was used as mobile phase A). The method used methanol as mobile phase B and the gradient programme is 0/05, 05/10, 10/15, 15/20, 25/stop. The detection was carried out at the wavelength 290nm. The developed method was validated with respect to linearity, accuracy, precision, system stability, selectivity, robustness to prove the stability indicating ability of the method.

Keywords: Rilpivirine HCl, RP-HPLC, inertsil ex C18 and validation.