Rilpivirine and Dolutegravir Simultaneously Measured via RP-HPLC-PDA with Box–Behnken Design Application: A Study of Forced Degradation under Various Conditions
نویسندگان
چکیده
Simultaneous estimation of rilpivirine (RLVN) and dolutegravir (DTGR) in bulk tablet dosage forms via RP-HPLC-PDA with a Box–Behnken design (BBD) has been performed this study to develop fast, precise, timely cost-saving method for estimating RLVN DTGR forms. The chromatographic conditions were optimized the BBD, developed was validated according ICH guidelines. Additionally, forced degradation studies also conducted. peaks observed at retention times 2.167 2.716 min, respectively, 6-min runtime. Kromasil 150 mm× 4.6 mm, 5 µm C 18 column used. flow rate mobile phase 1.0 mL/min temperature 30 °C. composition 0.1% OPA buffer acetonitrile (ACN) 60:40 ratio. Elutes measured 260 nm (max) after being injected sample volume 10 µL. assay result marketed 99.19% 99.09% DTGR, respectively. results different chemical environments such as acid, base, dry heat, photo-stability, neutral, oxidation (5.96, 4.79, 3.27, 2.36, 0.99, 4.35 percentage degradation) (5.67, 4.44, 4.09, 1.81, 0.43, 4.28 degradation). validation parameters within an acceptable range. newly formed is novel, time-saving, cost-effective.
منابع مشابه
A New Stability Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Dolutegravir and Rilpivirine in Bulk and its Dosage Forms
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ژورنال
عنوان ژورنال: Separations
سال: 2023
ISSN: ['2297-8739']
DOI: https://doi.org/10.3390/separations10030185