RP-HPLC DEVELOPMENT AND VALIDATION OF METHOD FOR THE DETERMINATION OF TENOFOVIR ALAFENAMIDE IN BULK AND TABLET DOSAGE FORM Authors: Ansari YA , SHAIKH MT, KHAN RA, INAMDAR ZE, QAZI SS, SHAIKH NS, ANSARI MR
ABSTRACT
A new RP-HPLC method was developed for estimation of Tenofovir Alafenamide. In RP-HPLC method, good resolution and separation of drug was achieved. Buffer, pH 5.0: Methanol (20:80) was used as mobile phase. Retention time of Tenofovir Alafenamide was found to be 5.050 min with a flow rate of 1.0 ml/min. The drug was found to be linear in concentration of 5-15 µg/ml. The developed method was validated for specificity, Linearity, Precision, LOD, LOQ and robustness of the system. The assay of marketed formulation was also performed, % purity of drug was found to be 96.007%. The proposed method was robust, accurate and precise. Therefore proposed method can be used for routine analysis of Tenofovir Alafenamide in tablets.
Keywords: HPLC, Method development, Method validation, Tenofovir Alafenamide, Anti-viral
Publication date: 01/08/2020 https://ijbpas.com/pdf/2020/August/MS_IJBPAS_2020_5129.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2020/9.8.5129