Nghiên cứu xây dựng và thẩm định phương pháp phân tích đồng thời methylparaben, epirubicin trong thuốc tiêm đông khô epirubicin 50 mg bằng sắc ký lỏng hiệu năng cao

Abstract

An HPLC method for simultaneous quantitative analysis of epirubicin hydrochloride (C₂₇H₂₉NO₁₁ HCI) methyl paraben (C₈H₈O₃ in the injectable lyophilized mixture with lastose monohydrate was established as: Column -Trirnethylsilyl silica gel (25 cm x 4.6 mm, 5µm); Column temperature - 35°C; Detector - UV (254 nm); Mobile phase - a mixture of methanol - acetonitrile - solution of sodium dodecyl sulfate 0.37 % (w/v) in orthophosphoric acid 0.28 M (17: 29: 54); Isocratic mode of elution, Flow rate - 2.5 ml/min; The procedure was validated to confirm system compatibility, define the linearity range, detection limit (LOD), quantitation limit (LOQ), accuracy, precision and repeatability.