Abstract

ANALYTICAL UV SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF RITONAVIR

Shilpa Zinjad*, Dyaneshwar Pawar, Shubhangi Warad, Sagar Jasud, Ganesh Jagdale, Shital Walunj

ABSTRACT

Analytical method development and validation plays an important role in the discovery, development and manufacture of pharmaceuticals. The official test methods that result from the processes are used by quality control laboratories to ensure the identity, purity, potency and performance of drug products. Ritonavir is frequently prescribed with highly active anti-retroviral therapy .The drug is commercially available as tablets for oral administration. In the present work two simple, economical, precise and accurate UV spectrophotometric methods have been developed for the estimation of Ritonavir in bulk and pharmaceutical formulation. Method A is absorption maxima method in which λmax was found to be 238 nm. Method B is area under the curve (AUC) in which area in the wavelength range of 230 nm – 246 nm was selected for analysis of Ritonavir. Linearity was observed in the concentration range 10-50μg/ml (r2 =0.999) for both the methods. The % assay for the marketed formulation for absorption maxima and area under the curve method was found to be 99.57%, and 100.88% respectively. The methods were validated with respect to linearity, precision and accuracy studies. Recovery studies for absorption maxima, and area under the curve was found to be 102.68%, and 100.09% respectively. The methods were found to be simple, precise and accurate and can be employed for routine quality control analysis of Ritonavir in bulk as well as from its dosage form.

Keywords: Ritonavir, Spectrophotometric method.