DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING UPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF DARUNAVIR, TENOFOVIR, EMTRICITABINE AND COBICISTAT IN BULK AND PHARMACEUTICAL DOSAGE FORMS
Dr. B. Rajkamal*, Ms. Gopanagoni Priyanka
ABSTRACT
Human immunodeficiency virus (HIV) remains a major global health concern, necessitating effective combination antiretroviral therapies and robust analytical methods for quality assurance. This study aimed to develop and validate a rapid, accurate, precise, and stability-indicating reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method for the simultaneous determination of darunavir, tenofovir alafenamide, cobicistat, and emtricitabine in bulk drug substances and pharmaceutical dosage forms. Chromatographic separation was achieved on an ACQUITY BEH C18 (100 × 2.1 mm, 1.7 µm) column using 0.1% orthophosphoric acid buffer and acetonitrile (55:45, v/v) as the mobile phase at a flow rate of 0.30 mL/min, with detection at 260 nm. Complete separation of all analytes was achieved within 5 min. The method was validated in accordance with ICH Q2(R2) guidelines and demonstrated excellent specificity, linearity (R² > 0.999), precision (%RSD < 2.0), accuracy, robustness, and sensitivity. Forced degradation studies under acidic, alkaline, oxidative, thermal, photolytic, and neutral hydrolytic conditions confirmed the stability-indicating capability of the method. The validated procedure was successfully applied to the assay of marketed formulations, yielding results within acceptable pharmacopeial limits. The proposed RP-UPLC method is suitable for routine quality control, stability testing, and regulatory analysis of these antiretroviral drugs.
Keywords: Darunavir; Tenofovir Alafenamide; Emtricitabine; Cobicistat; RP-UPLC; Stability-indicating method; Method validation.
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