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VALIDATION QUALITY METHOD FOR ROTUNDINE SULFATE IN ROTUNDINE SULFATE INJECTION BY HIGH PERFOMANCE LIQUID CHROMATOGRAPHY
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Abstract
Objective: To validate the assay method for the quantification of rotundine sulfate in rotundine sulfate injection by high performance liquid chromatography (HPLC) in order to contribute to standardization of product quality. Methods: Quantification of Rotundine sulfate was carried out by HPLC method with chromatographic column C18 (4.6×150 mm, 5 µm), flow rate 1.0 mL/min, PDA detector at 281 nm, sample injection volum: 15μL, mobile phase solvent: acetonitrile: water (70:30). Results: The method ensured suitability, specificity, linearity, repeatability, precision, and limits of detection as specified by ICH. Conclusion: The quantitative method responded the requirements and can be used to quantify rotundine sulfate in injection.
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Keywords
Rotundine sulfate, injection, ICH
References
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