Pemra Raju et al,. Int J Indig Herbs Drugs 2021;6(2):49-57 49 International Journal of Indigenous Herbs and Drugs Open Access ISSN: 2456-7345 Development and Validation of New Analytical Method for The Simultaneous Estimation of Darunavir And Ritonavir in Pharmaceutical Dosage Form Pemra Raju* 1 , K. Thejomoorthy 2 , P.Sreenivasa Prasanna 3 1 Department of Pharmaceutical analysis, M.L.College of Pharmacy, S. Konda-523101. 2 Head, Department of Pharmaceutical analysis, M.L.College of Pharmacy, S. Konda-523101. 3 Principal, M.L.College of Pharmacy, S.Konda-523101. Article Info : Abstract Article History Received on: 03-03-2021 Revised on : 1-04-2021 Accepted on : 25-04-2021 Keywords: Darunavir, Ritonavir, RP-HPLC. 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. Introduction Pharmaceutical products formulated with more than one drug, typically referred to as combination products. These combination products can present daunting challenges to the analytical chemist responsible for the development and validation of analytical methods. The development and validation of analytical methods Spectrophotometric, High performance liquid chromatography (HPLC) and High-performance thin layer chromatography (HPTLC) for drug products containing more than one active ingredient. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products. The number of drugs introduced into the market is increasing every year. These drugs may be either new entities or partial structural modification of the existing ones. Very often there is a time lag from the date of introduction of a drug into the market to the date of its inclusion in pharmacopoeias. This happens because of the possible uncertainties in the continuous and wider usage of these drugs, reports of new toxicities (resulting in their withdrawal from the market), development of patient resistance and introduction of better drugs by competitors. Under these conditions, standards and analytical procedures for these drugs may not be available in the pharmacopoeias. It becomes necessary, therefore to develop newer analytical methods for such drugs 3 Darunavir [1] (DRV) is chemically (3R,3aS,6aR)- hexahydrofuro[2,3-b]furan-3-yl N-[(2S,3R)- 3-hydroxy-4- [N-(2-methylpropyl)4- aminobenzenesulfonamido]-1- phenylbutan2yl] carbamate Figure 1. It is a protease inhibitor used to treat HIV. It acts on the HIV aspartyl protease which the virus needs to cleave the HIV polyprotein into its functional fragments This article is licensed under a Creative Commons Attribution-Non Commercial 4.0 International License. Copyright © 2021 Author(s) retain the copyright of this article. *Corresponding Author Pemra Raju Email: mlcollegeofpharmacy@gmail.com Doi: https://doi.org/10.46956/ijihd.vi.157 Production and Hosted By Saap.org.in Research Article