Abstract

A NOVEL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF CABOTEGRAVIR BY UV SPECTROSCOPIC METHOD

Santhosh Illendula*, Dr. Suthakaran Raj, Ananthula Srujana, Thummanapelly Ananthalaxmi, Pippalla Poojitha, Nenavath Meghanath, Bottu Deepthi and Rakthanala Rakesh

ABSTRACT

A new simple, accurate, rapid, precise, reproducible and cost-effective spectrophotometric method for the quantitative estimation of Cabotegravir in bulk and pharmaceutical dosage form. The developed visible spectrophotometric method for the quantitative estimation of Cabotegravir is based on measurement of absorption at maximum wavelength 260 nm using 0.1% Phosphoric acid (buffer) : Acetonitrile (50:50 % v/v) as a solvent. The stock solution of Cabotegravir was prepared, and subsequent suitable dilution was prepared in diluent to obtained standard curve. The standard solution of Cabotegravir shows absorption maxima at 260 nm. The drug obeyed beer lambert’s law in the concentration range of 5 - 25 μg/ml with regression 0.999998 at 260 nm. The overall % recovery was found to be 99.43% which reflects that the method was free from the interference of the impurities and other excipients used in the bulk and marketed dosage form. The low value of % RSD was indicative of accuracy and reproducibility of the method. The % RSD for inter-day and intra-day precision was found to be 0.361687 and 0.357177 respectively which is<2% henceproved that method is precise. The results of analysis have been validated as per International Conference on Harmonization (ICH) guidelines. The developed method can be adopted in routine analysis of Cabotegravir in bulk and tablet dosage form.

Keywords: Cabotegravir, UV Visible Spectrophotometer, Method development, Validation, ICH guidelines, Acetonitrile, Accuracy.