Background:A simple, precise, accurate, and rapid reverse phase-high performance liquid chromatography (RP-HPLC) method with UV-Visible detector has been developed and subsequently validated for the simultaneous determination of tenofovir disoproxil fumarate (TDF), lamivudine (LAMI), and efavirenz (EFV) in their combined tablet dosage form.Materials and Methods:The separation was based on the use of a Kromasil C18 analytical column (150 × 4.6 mm, i.d., 5 μm). The mobile phase consisted of a mixture of 70 volumes of methanol and 30 volumes of 10 mM phosphate buffer (pH 5.0). The separation was carried out at 40°C temperature with a flow rate of 1 ml/min.Results:Quantitation was achieved with UV detection at 254 nm, with linear calibration curves at concentration ranges of 1–6 μg/ml for TDF and LAMI and 2–12 μg/ml for EFV. The recoveries obtained were 99.46–101.36% for LAMI, 99.57–101.42% for TDF, and 99.96–100.87 for EFV.Conclusion:The method was validated according to International conference of harmonisation guidelines in terms of accuracy, precision, specificity, robustness, limits of detection and quantitation, and other aspects of analytical validation.
Aim:A simple, precise and accurate RP-HPLC method with UV-Visible detector has been developed and subsequently validated for the simultaneous determination of propranolol hydrochloride (PRP) and flunarizine dihydrochloride (FLU) in their combined dosage formulation. Materials and Methods: The separation was based on the use of a Kromasil C8 analytical column (150 × 4.6 mm, i.d., 5 μm). The mobile phase consisted of a mixture of 70 volumes of methanol and 30 volumes of 10 mM phosphate buffer (pH 3.8). The separation was carried out at 40°C temperature with a flow rate of 0.8 ml/ min. Result and Conclusion: Quantitation was achieved with UV detection at 242 nm, with linear calibration curves at concentration ranges of 32-72 μg/ml for PRP and 8-18 μg/ml for FLU. The recoveries obtained were 98.97-101.10% and 98.86-102.27% for PRP and FLU, respectively. The method was validated according to the ICH guidelines in terms of linearity, accuracy, precision, specificity, robustness, limits of detection, limit of quantitation, and system suitability of analytical method validation.
Chemicals and reagentsReference standards of PRP and FLU were kindly supplied by Yarrow Chem Ltd. (Mumbai, India) and Esquire Pharmaceutics (Surendranagar, India), respectively, as a gift sample. All reagents used were of HPLC grade, namely, methanol, water and ortho-phosphoric acid (80%) (Finar
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.