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Development and validation of a simultaneous HPLC method for quantification of ketoprofen and methylparaben in topical gel
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Tóm tắt
This study has developed a method for simultaneous quantification of ketoprofen and methylparaben in topical gel by reversed-phase HPLC. The method was performed on a Phenomenex C18 column (4.6 mm × 250 mm; 5 µm), using a mobile phase of acetonitrile – 0.1% ortho phosphoric acid (50 : 50, v/v) under isocratic conditions, at a flow rate of 1.0 mL/min, column temperature 35°C, UV detection at 254 nm, and injection volume of 10 µL. The method was validated for specificity, system suitability, linearity, accuracy, precision (repeatability and intermediate precision) in accordance with ICH Q2(R2) guidelines and AOAC 2016. Validation results demonstrated that the method is suitable for simultaneous determination of ketoprofen and methylparaben in topical gel and can be applied in quality control laboratories.
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Từ khóa
Simultaneous quantification, ketoprofen, methylparaben, HPLC, topical gel
Tài liệu tham khảo
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