Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP HPLC METHOD FOR ESTIMATION OF DARUNAVIR AND ITS RELATED SUBSTANCE IN TABLET DOSAGE FORM

Kajal P. Patel*, Mitali Jasani, Dr. Chirag J. Patel and Dr. M. M. Patel

Abstract

To develop simple, precise, rapid and accurate reverse phase HPLC method for estimation of darunavir and its related dosage form in tablet dosage form. The adequate chromatographic separation was performed on Inertsil C8 column (250mm×4.6mm) 5μm using gradient elution. Other HPLC parameter which were optimised flow rate 1.5 ml/min; the effluent was monitored at 265 nm, column oven temperature 50ºC injection volume 5 μl and run time was 80min The development method was statistically validated for linearity (1-4.5 ppm). Forced degradation study revealed that drug was sensitive to Acid, Base, Peroxide degradation, in other condition not adequate degradation observed. The accuracy of the present method was evaluated at 50%, 100%, 150% was found to be within limits 80-101%. Precision studies were carried out and RSD values were less than 5. The Method was found to be robust. The proposed method was found to be specific, accurate, precise and linear can be used for estimation of darunavir in tablet dosage form.

Keywords: RP HPLC, Darunavir, Pharmaceutical dosage form.