Volume : 09, Issue : 10, October – 2022

Title:

48.ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF CABOTEGRAVIR & RILPIVIRINE BY RP HPLC METHOD
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Authors :

Pindi Shravani, Dr. Nihar Ranjan Das

Abstract :

A new method was established for simultaneous estimation of and cabotegravir and rilpivirine by RP-HPLC method. The Phosphate buffer was pH 3.2 and the mobile phase was optimized which consists of Acetonitrile: Phosphate buffer mixed in the ratio of 40:60 % v/ v. A Inertsil ODS C18 (4.6 x 250mm, 5 µm, Make Waters) column used as stationary phase. The detection was carried out using UV detector at 231 nm. The solutions were obtained at a constant flow rate of 1.0 ml/min. The linearity range of cabotegravir and rilpivirine were found to be from 20-60g/ml and 30-90g/ml respectively. linear regression coefficient was not more than 0. 999.The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98-102% of Cabotegravir and Rilpivirine LOD and LOQ was found to be within limit.
Key words: Cabotegravir and Rilpivirine, RP-HPLC, Acetonitrile.

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References:

1. FDA Approved Drug Products: Vocabria (Cabotegravir) Oral Tablets
2. FDA Approved Drug Products: Cabenuva (Cabotegravir and Rilpivirine) Intramuscular Extended-Release Suspension
3. Putcharoen O, Kerr SJ, Ruxrungtham K: An update on clinical utility of rilpivirine in the management of HIV infection in treatment-naive patients. HIV AIDS (Auckl). 2013 Sep 16;5:231-41. doi: 10.2147/HIV.S25712. [Article]
4. Usach I, Melis V, Peris JE: Non-nucleoside reverse transcriptase inhibitors: a review on pharmacokinetics, pharmacodynamics, safety and tolerability. J Int AIDS Soc. 2013 Sep 4;16:1-14. doi: 10.7448/IAS.16.1.18567. [Article]
5. Azijn H, Tirry I, Vingerhoets J, de Bethune MP, Kraus G, Boven K, Jochmans D, Van Craenenbroeck E, Picchio G, Rimsky LT: TMC278, a next-generation nonnucleoside reverse transcriptase inhibitor (NNRTI), active against wild-type and NNRTI-resistant HIV-1. Antimicrob Agents Chemother. 2010 Feb;54(2):718-27. doi: 10.1128/AAC.00986-09. Epub 2009 Nov 23.
6. Jomol Joseph, N.J.R. Hepsebah, K. Deepthi. Analytical method development and validation for the simultaneous estimation of Dolutegravir and Rilpivirine using RP-HPLC method in both bulk and pharmaceutical dosage forms. European j. biomed. pharm.. (2016) 3 (5): 237-243.
7. Kavitha K.Y, Geetha G, Hariprasad.R, Venkatanaraynan R, Kaviarasu M. Development and validation of RP-UPLC analytical method for simultaneous estimation of Emtricitabine, Rilpivirine, Tenofovir disoproxil fumarate and its pharmaceutical dosage forms. Int. Res. J. Pharm. (2013) 4 (1): 150-155.
8. Gregoire.M, Deslandes.G, Renaud.C, Bouquie.R. A liquid chromatography-Tandem Mass Spectrometry Assay for Quantification of Rilpivirine and Dolutegravir in Human Plasma. Chromatography (2014) 971: 1- 9.
9. Somaubhra Ghosh, SowjanyaBomma, V. Laxmi Prasanna, S. Vidyadhar, David Banji, Subhadip Roy. Method development and validation of Rilpivirine in bulk and tablet dose form by RP-HPLC method. Res. J. Pharm. Technol. (2013) 6 (3): 240-243.
10. BhavarGirijaBalasaheb, Aher Kiran Balasaheb, Thorat Ravindra Subhash, KakadsachinJijabapu, Pekamwar Sanjay Sudhakar. Development and validation of UV spectrophotometric method for estimation of Dolutegravir sodium in tablet dosage form. Malaysian J. Anal. Sci. (2015) 19(6): 1156- 1163.