A Novel Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Bictegravir, Emtricitabine and Tenofovir in Pure and Fixed Dose Combination

Abstract

A novel, simple, precise, accurate stability indicating liquid chromato-graphy method was developed for the separation and simultaneous quantification of bictegravir, emtricitabine, tenofovir in bulk drug and pharmaceutical formulations. Separation was achieved on ProntoSILHypersorb ODS C18 column using mobile phase of 0.1 M sodium perchlorate, methanol in the ratio of 65:35 (v/v), pH 4.8 at a flow rate of 1.0 mL/min and UV detection was monitored at a wavelength of 258 nm. In these conditions, well resolved peaks were observed with acceptable system suitability at a retention time of 4.6 min for bictegravir, 7.0 min for emtricitabine and 10.1 min for tenofovir. Very high correlated linearity range was found to be 5-30 μg/mL for bictegravir, 20-120 μg/mL for emtricitabine and 2.5-15 μg/mL for tenofovir. The method can separate and identify the unknown degradation compounds formed during stress degradation study.

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“…The literature review reveals that there are very few methods developed for the simultaneous estimation of emtricitabine, bictegravir, and tenofovir alafenamide in their bulk and pharmaceutical dosage forms, such as reversed-phase highperformance liquid chromatography (RP-HPLC) [10][11][12][13][14][15] , UPLC 16,17 and liquid chromatography-tandem mass spectrometry (LC-MS/MS) 18 . The objective of the present study was to develop and validate a UPLC method for the simultaneous determination of emtricitabine, bictegravir, and tenofovir alafenamide in the pharmaceutical dosage form.…”

Development, Validation and Forced Degradation Study of Emtricitabine and Tenofovir Alafenamide in its Pharmaceutical Dosage Form Using RP-HPLC

“…Emtricitabine (EMT) is an analogue of 1). Tenofovir Alafenamide (TEN) is a nucleotide reverse transcriptase inhibitor RTI) and a novel ester prodrug of the [3], HPTLC [4], RP Stability Indicating RP-HPLC [6], Bioanalytical LC-MS [7] etc. but no any RPhave been reported for the estimation of specifically EMT and TEN.…”

“…Validation results of method was found within quality, safety and efficiency of product. The literature survey reveals that these drugs have been analyzed along with many other Anti-HIV agents by analytical methods like spectrophotometric [3], HPTLC [4], RP-HPLC [5], HPLC [6], Bioanalytical HPLC method have been reported for the estimation of specifically EMT and TEN. Before commercial production, the company need to perform the process validation of TEN and EMT dosage forms for assurance of the quality.…”