Abstract: Abacavir, Dolutegravir, and Lamivudine, as well as Cabotegravir and Rilpivirine, are five ART regimens that successfully control HIV-1 replication and prevent sexual transmission when taken together once daily by mouth (as a fixed-dose combination). This review provides a general outline and critical commentary of publications in the last two decades (2004–2024) covering analytical methods developed for quantification of these drugs. These agents, belonging to diverse pharmacological classes—nucleoside reverse transcriptase inhibitors (NRTIs), integrase strand transfer inhibitors (INSTIs), and non-nucleoside reverse transcriptase inhibitors (NNRTIs)-demonstrate potent antiviral activity with favourable pharmacokinetics. Due to the high usage of these drugs in both monotherapy and combination therapy, the availability of reliable, validated analytical and bioanalytical methods for their quality assurance, stability testing, and treatment monitoring is highly essential. Methods such as UVvisible spectrophotometry, RP-HPLC, UHPLC, and LC-MS/MS were systematically validated for various parameters, viz., linearity, precision (intra-day and inter-day), accuracy, specificity, and robustness, in conformity with ICH guidelines as well as FDA and EMA guidance. The review emphasizes stability-indicating methods, impurity profiling, chemometric optimization, and high-throughput simultaneous determination in complex dosage forms. In addition, it discusses method performance characteristics among platforms and highlights the increasing importance of LC-MS/MS in ultra-sensitive bioanalysis for therapeutic drug monitoring and pharmacokinetic investigations. An integrated tabular description allows for quick method selection for regulatory, clinical, or industrial use. In summary, the present review delivers important information about the analytical scenario of these major drugs, providing a useful reference to researchers, analysts, and regulatory scientists in the area of pharmaceutical analysis.
Nagabathula et al. (Wed,) studied this question.