EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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ISSN 2394-3211

Impact Factor: 7.065

ICV - 79.57

Abstract

A STUDY ON HPLC METHOD DEVELOPMENT AND VALIDATION OVER SOFOSBUVIR AND SIMEPREVIR TABLET DOSAGE FORM

Ram Kumar Kandasamy*, Anbarasi Balakrishnan, Vijayamitharaj Ramaswamy and Senthilkumar Natesan

ABSTRACT

The simultaneous quantitative analysis of Sofosbuvir and Simeprevir in tablet dosage form has been developed and validated using high-performance liquid chromatography (HPLC). Specificity, precision, accuracy, and reproducibility of the method made it suitable for routine quality control testing in industries. Simeprevir and Sofosbuvir had retention times of 2.512 minutes and 3.116 minutes, respectively. Sofosbuvir and Simeprevir were found to have a good level of precision with %RSD values of 0.2 and 0.7, respectively. For Sofosbuvir, the %Recovery values were 99.44%, while for Simeprevir, they were 99.96%, indicating excellent accuracy. A regression equation was used to determine the LOD (limit of detection) and LOQ (limit of quantification) of the method. A LOD of 0.38 and a LOQ of 1.17 were determined for Sofosbuvir, whereas 0.11 and 0.34 were determined for Simeprevir. A linear regression equation was established for Sofosbuvir and Simeprevir as y = 11806x + 1985.4 and y = 9492.1x + 514.5, respectively, ensuring linearity and providing a reliable method of quantification. ICH guidelines were followed for validating the method, including linearity, accuracy, precision, LODs, LOQs, robustness, and reproducibility. This study confirmed that the method was reliable and suitable for routine analysis based on the validation results. This method is also simple and cost-effective due to its decreased retention times and reduced run times. As a result, it is a highly practical testing method for quality control in industrial settings. As a result, the HPLC method proposed provides a robust and efficient method for simultaneously analyzing Sofosbuvir and Simeprevir tablets. A valuable tool in the pharmaceutical industry for quality control, it is simple, specific, precise, accurate, and cost-effective.

Keywords: Sofosbuvir, Simeprevir, validation, HPLC, Quality control.

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