Analytical method development and validation of Tenofovir Alafenamide by using RP-HPLC of bulk drug

Authors

  • P.B. Dudhe Department of Pharmaceutical Chemistry, Sinhgad College of Pharmacy, Vadgaon (Bk), Pune – 411041, Maharashtra, India.
  • E. Choudhary Department of Pharmaceutical Chemistry, Sinhgad College of Pharmacy, Vadgaon (Bk), Pune – 411041, Maharashtra, India.
  • A. Bhujbale Department of Pharmaceutical Chemistry, Sinhgad College of Pharmacy, Vadgaon (Bk), Pune – 411041, Maharashtra, India.
  • B. Khandare Department of Pharmaceutical Chemistry, Sinhgad College of Pharmacy, Vadgaon (Bk), Pune – 411041, Maharashtra, India.
  • M. Dhoke Department of Pharmaceutical Chemistry, Sinhgad College of Pharmacy, Vadgaon (Bk), Pune – 411041, Maharashtra, India.

Keywords:

C18, HPLC, Methanol, Tenofovir alafenamide,

Abstract

A fast, simple, sensitive, precise and reproducible (liquid chromatography) RP-HPLC method was developed and validated for the analysis of Tenofovir alafenamide bulk dosages form. The separation was conducted by using C-18 HPLC column. Which was maintained at ambient temperature. The mobile phase consist of methanol (100 v/v) was delivered at a rate of 1mL/min. The analysis was detected by using UV detector at the wavelength 259 nm. The method was validated for its precision, limit of quantitiation (LOQ) linearity and robustness. The method was found to be linear over the concentration range 10-100 μg/mL (r2 =0.999). The retention time for Tenofovir alafenamide was found to be 4.107± 25 min. limit of quantitation of method was 6.3139 μg/mL and limit of detection 2.0836μg/mL. Thus, the developed method is found to be robust and rugged which can be applied as a rapid tool for routine analysis of tenofovir alafenamide in the bulk and in the pharmaceutical dosage form.

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Published

2022-09-01