Rp-HPLC (Stability-Indicating) Based Assay Method for the Simultaneous Estimation of Doravirine, Tenofovir Disoproxil Fumarate and Lamivudine

Abstract

Objective: In this study, a RP-HPLC (stability-indicating) based assay method for the estimation of doravirine (DRV), tenofovir disoproxil fumarate (TFF) and lamivudine (LMV) simultaneously in the tablets was described.
 Methods: The simultaneous analysis of DRV, TFF and LMV was done with HPLC system (Agilent 1100 series) and Luna Phenomenex C18 (250 mm × 4.6 mm × 5 μ) column with isocratic mobile phase (35% volume ratio of methanol and 65% volume ratio of 20 mmol ammonium formate, pH 5). Validation of assay method was done on sensitivity, linearity, accuracy, selectivity, precision, robustness and specificity.
 Results: The calibration curves were linear through the range of 25-200 µg/ml for DRV and 75-600 µg/ml for TFF and LMV. The percent relative standard deviation for intraday variation/precision, interday variation/precision, intermediate precision/ruggedness and robustness were lower than 2%. The recovery of LMV (99.09-99.76%), TFF (99.10-99.41%) and DRV (98.65-99.28%) confirmed the good accuracy. The stability of LMV, TFF and DRV in 0.1N NaOH, 3% peroxide, 0.1 N HCl, UV light and dry heat of 60 °C was determined.
 Conclusion: The results have allowed the method to be implemented in the tablets to quantify DRV, TFF, and LMV.

A Validated Stability Indicating Rp-HPLC Method for Estimation of Avapritinib in Bulk and Tablet Dosage Form

“…Only a validated method should be employed for the estimation of drugs. The developed method was validated following the ICH Q2 (R1) guidelines and other literatures using the prescribed validation parameters [19][20][21][22][23][24][25][26][27][28][29][30].…”

HPTLC Method for Simultaneous Estimation of Lamivudine, Tenofovir Disoproxil Fumarate, and Doravirine

“…The literature search reveals that various analytical techniques have been employed for the quantification of DOR (Doravirine), TDF (Tenofovir disoproxil fumarate), and LMV (Lamivudine), both in combination and individually. Some of the widely used methods include high-performance liquid chromatography (HPLC) and ultraperformance liquid chromatography (UPLC), which have been referenced in several studies [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16]. Additionally, a high-pressure thin-layer chromatography (HPTLC) method has been reported for the quantification of LMV and TDF alone and in combination [17][18][19][20][21][22][23][24][25][26].…”

“…Previous literature searches revealed that various other analytical techniques, such as high-performance liquid chromatography (HPLC) [2][3][4][5][6][7][8][9][10][11][12][13], ultra-performance liquid chromatography (UPLC) [14][15][16], have been employed for the quantification of DOR, TDF, and LMV in combination and alone. High-pressure thin layer chromatography (HPTLC) [17][18][19][20][21][22][23][24][25][26] method has been reported for quantification alone and in combination with LMV and TDF.…”

Development and Validation of New Rp-Hplc Method for The Simultaneous Estimation of Lamivudine, Tenofovir and Doravirine in Pharmaceutical Dosage Form

“…It was approved by the US Food and Medication Administration in 2018 as a complete drug regimen for HIV type 1 infection in patients who had not previously received antiretroviral therapy [12]. According to the literature, few techniques have been published for estimating Lamivudine, Tenofovir, and Doravirine alone and in combination with various dosage forms utilising UV, HPLC methods [13][14][15]. There is no known technique for determining assay and simultaneous estimate of Lamivudine, Tenofovir, and Doravirine in combination dose form.…”