Development and Validation of New Analytical Method for The Simultaneous Estimation of Darunavir And Ritonavir in Pharmaceutical Dosage Form

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Darunavir and Ritonavir in Tablet dosage form. The chromatogram was run through Agilent C18 150 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1% Formic acid: Acetonitrile, taken in the ratio 70:30 was pumped through the column at a flow rate of 0.95 ml/min. The temperature was maintained at 30°C. The optimized wavelength selected was 293 nm. The retention times of Darunavir and Ritonavir were found to be 2.369min and 2.911. %RSD of the Darunavir and Ritonavir were and found to be 0.7 and 0.5 respectively. %Recovery was obtained as 99.67% and 99.78% for Darunavir and Ritonavir respectively. LOD, LOQ values obtained from regression equations of Darunavir and Ritonavir were 1.49, 5.191and 0.37, 1.11 respectively. Regression equation of Darunavir is y = 5421x + 640.7, and y = 3870.x + 5191 of Ritonavir. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control tests in Industries.

Quality by design tool–evaluated stability‐indicating ultra‐performance liquid chromatography method for the determination of drugs (ritonavir and darunavir) used to treat the human immunodeficiency virus/acquired immunodeficiency syndrome

“…So far, only a few analytical techniques have been published for the chromatographic analysis of combination formulation, either separately or together. According to the literature review (Abduljalil & Badhan, 2016;Chiranjeevi & Channabasavaraj, 2011;Ettaboina et al, 2022;Grace & Parthiban, 2022;Jagadeeswaran et al, 2012;Kashish et al, 2020;Kavitha, 2020;Kumar et al, 2016;Lathouwers et al, 2011;Masaaki et al, 2021;Mishra & Shrivastav, 2014;Muchakayala et al, 2022;Pappula & Naresh, 2022;Patel et al, 2013;Paul et al, 2021;Raju et al, 2021;Rezk et al, 2009;Sabyasachi et al, 2021) none of these methods was found suitable for a stability-indicating analysis for quality control use.Thelonger run time used for quantification makes methods time consuming and cost-effective. In general, the technique should be enhanced or its robustness should be proven using the quality by design (QbD) approach, according to the present regulatory criteria, which are unambiguous.…”