Abstract

SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR DOLUTEGRAVIR SULPHATE BY ULTRAVIOLET SPECTROSCOPY (UV) AND HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)

*Ankita Onkar Ghayal, Dr. Ananta U. Gite, Dr. Nandu R. Kayande, Divakar S. Jagtap

Abstract

This study focuses on the development and validation of simple, precise, and accurate analytical methods for the estimation of Dolutegravir sulphate in bulk and tablet dosage form using UV spectrophotometric and RP-HPLC techniques. The UV method was performed at a wavelength of 259.80 nm, while the RP-HPLC method utilized a C-18 column with a mobile phase consisting of Acetonitrile and phosphate buffer (75:25 v/v) at a flow rate of 0.8 ml/min. The developed methods were validated as per ICH guidelines for parameters such as linearity, precision, accuracy, robustness, ruggedness, limit of detection (LOD), and limit of quantitation (LOQ). The linearity range for UV method was found to be 5–40 μg/ml and for HPLC method 10–50 μg/ml with correlation coefficients close to 0.999, indicating excellent linearity. The %RSD values for precision studies were found to be less than 2%, confirming high precision of the methods. Accuracy studies showed % recovery in the range of 99–101%, indicating the reliability of the methods. The developed methods were found to be robust and rugged under varying experimental conditions. The assay of marketed formulation showed drug content within acceptable limits. In conclusion, the proposed UV and RP-HPLC methods are simple, accurate, precise, and suitable for routine quality control analysis of Dolutegravir sulphate in pharmaceutical dosage forms.

Keywords: Dolutegravir sulphate, UV spectrophotometry, RP-HPLC, Method validation, ICH guidelines.