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<p>The increasing global reliance on fixed-dose combinations (FDCs) of antiretroviral drugs (ARVs) for the treatment of HIV/AIDS underscores the critical need for robust, reliable, and validated analytical methods for their simultaneous quantification. This multi-part review presents an in-depth and systematic evaluation of analytical methodologies developed for the determination of dual antiretroviral combinations in pharmaceutical formulations, with a primary focus on High-Performance Liquid Chromatography (HPLC) and High-Performance Thin-Layer Chromatography (HPTLC). The review explores key parameters influencing method performance, including column type, mobile phase composition, pH, buffer systems, detection wavelengths, flow rates, validation criteria (specificity, accuracy, precision, linearity, LOD, LOQ), and robustness. For each drug combination, published HPLC methods—especially reversed-phase HPLC (RP-HPLC)—are analyzed in terms of sensitivity, selectivity, and applicability for routine quality control. The role of Ultra-Performance Liquid Chromatography (UPLC) in achieving faster analysis times and enhanced sensitivity is also discussed. Stability-indicating methods and design of experiments (DOE)-based optimizations further highlight the sophistication of recent method development strategies. Complementing this, the review examines HPTLC techniques as an accessible alternative, particularly in resource-limited settings, noting its advantages in simplicity and throughput despite limitations in sensitivity, reproducibility, and regulatory acceptance. Multiple solvent systems, detection wavelengths, and optimization strategies are compared across studies to determine best-fit methods for specific analyte pairs, including lamivudine with zidovudine, dolutegravir, abacavir, tenofovir, and efavirenz. This review integrates publications from 2007 onward sourced from reputable scientific databases and critically compares the analytical performance of reported methods for over ten commonly prescribed dual combinations such as DTG/3TC, 3TC/TDF, DTG/RPV, CAB/RPV, FTC/TAF, ATV/COB, DRV/COB, ABC/3TC, 3TC/ZDV, LPV/RTV, and EFV/3TC. It highlights trends in method optimization, identifies gaps in sensitivity or validation data, and proposes future research directions to enhance analytical reliability and regulatory compliance. Overall, this work serves as a valuable resource for pharmaceutical analysts, formulators, and regulatory scientists, offering detailed guidance for selecting and developing suitable chromatographic methods to ensure the quality, safety, and efficacy of antiretroviral therapies in diverse clinical and manufacturing contexts.</p>

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Liquid chromatographic determination of dual therapy components in anti-HIV products: a review

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月17日

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  • Imad O. Abu Reid,
  • Sayda M. Osman,
  • Somia M. Bakheet

摘要

The increasing global reliance on fixed-dose combinations (FDCs) of antiretroviral drugs (ARVs) for the treatment of HIV/AIDS underscores the critical need for robust, reliable, and validated analytical methods for their simultaneous quantification. This multi-part review presents an in-depth and systematic evaluation of analytical methodologies developed for the determination of dual antiretroviral combinations in pharmaceutical formulations, with a primary focus on High-Performance Liquid Chromatography (HPLC) and High-Performance Thin-Layer Chromatography (HPTLC). The review explores key parameters influencing method performance, including column type, mobile phase composition, pH, buffer systems, detection wavelengths, flow rates, validation criteria (specificity, accuracy, precision, linearity, LOD, LOQ), and robustness. For each drug combination, published HPLC methods—especially reversed-phase HPLC (RP-HPLC)—are analyzed in terms of sensitivity, selectivity, and applicability for routine quality control. The role of Ultra-Performance Liquid Chromatography (UPLC) in achieving faster analysis times and enhanced sensitivity is also discussed. Stability-indicating methods and design of experiments (DOE)-based optimizations further highlight the sophistication of recent method development strategies. Complementing this, the review examines HPTLC techniques as an accessible alternative, particularly in resource-limited settings, noting its advantages in simplicity and throughput despite limitations in sensitivity, reproducibility, and regulatory acceptance. Multiple solvent systems, detection wavelengths, and optimization strategies are compared across studies to determine best-fit methods for specific analyte pairs, including lamivudine with zidovudine, dolutegravir, abacavir, tenofovir, and efavirenz. This review integrates publications from 2007 onward sourced from reputable scientific databases and critically compares the analytical performance of reported methods for over ten commonly prescribed dual combinations such as DTG/3TC, 3TC/TDF, DTG/RPV, CAB/RPV, FTC/TAF, ATV/COB, DRV/COB, ABC/3TC, 3TC/ZDV, LPV/RTV, and EFV/3TC. It highlights trends in method optimization, identifies gaps in sensitivity or validation data, and proposes future research directions to enhance analytical reliability and regulatory compliance. Overall, this work serves as a valuable resource for pharmaceutical analysts, formulators, and regulatory scientists, offering detailed guidance for selecting and developing suitable chromatographic methods to ensure the quality, safety, and efficacy of antiretroviral therapies in diverse clinical and manufacturing contexts.