Open AccessStability Indicating RP-HPLC Method for the Simultaneous Quantification and Validation of Doravirine, Lamivudine and Tenofovir Disoproxil Fumarate in Bulk and Tablet Dosage Form and its Applications in Dissolution Studies
Author(s) -
Saba Yousuf,
Iffath Rizwana
Publication year - 2022
Publication title -
international journal of pharmaceutical sciences review and research
Language(s) - English
Resource type - Journals
ISSN - 0976-044X
DOI - 10.47583/ijpsrr.2022.v72i02.018
Subject(s) - high performance liquid chromatography , chromatography , chemistry , tenofovir , lamivudine , dosage form , forced degradation , ammonium acetate , human immunodeficiency virus (hiv) , medicine , virus , virology , hepatitis b virus
The study established and afterwards validated an “stability indicating RP–HPLC” stratagem for assessing lamivudine (LAD), doravirine (DOR), & tenofovir (TED). RP-HPLC separation & assessment of LAD, DOR & TED was accomplished with a mobile phase of KH2PO4 (0.1M concentration, 5.2 units pH) plus methanol solvent solutions at a 65:35 v/v percentage and 1 ml/min flow stream. The detector arranged at 237 nm. Elution times for LAD is 2.531 min, DOR is 5.691 min & TED is 3.530 min. The “stability indicating RP–HPLC” stratagem was proved quantity varied from 150 to 450 μg/ml for LAD, from 50 to 150 μg/ml for DOR & from 150 to 450 μg/ml for TED. Acceptable assessments were documented in precision study (RSD% - 0.230% for LAD; RSD% - 0.187% for TED; & %RSD – 0.264% for DOR) and accuracy study (recovery % - 98.98% for LAD; recovery% - 99.16% for TED; & recovery% – 98.53% for DOR). Robustness of “stability indicating RP–HPLC” stratagem also was discovered to be acceptable. Also, during degradation check, obstruction in the evaluation of the LAD, DOR & TED wasn't really discovered. The created “stability indicating RP–HPLC” stratagem also proved significant in a dissolution assessment of Delstrigo tablets comprising LAD, DOR, & TED as active components in combo.