Vijayalakshmi Marella, K. Lalitha, M. Pravallika, B. N. Nalluri
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引用次数: 3
摘要
目的:建立简便、快速、重现性好的反相高效液相色谱法测定帕罗西汀纯品及片剂的含量。方法:采用C18色谱柱(250x4.6 mm, 5μm)优化方法，流动相为10mM甲酸铵与乙腈，比例为50:50v/v，等压流速为1ml/min。检测波长为220nm。结果:在5 ~ 25 μg/ml浓度范围内，标定曲线呈线性关系。根据ICH Q2R1指南对该方法的线性度、精密度、准确度、稳定性和特异性进行了统计验证，结果表明该方法具有稳健性。定量限和定量限分别为0.748和2.62 μg/ml。结论:该方法精密度高，准确度高，可用于帕罗西汀制剂、生物液、溶出度的质量控制。
Novel RP-HPLC Method for the Determination of Paroxetine in Pure Form and in Tablet Formulation
Aim: To provide simple, rapid, reproducible reverse phase HPLC method for the estimation of paroxetine in pure form and tablet formulation. Method: The method is optimised using an inertsil column C18 (250x4.6 mm, 5μm) with the mobile phase consists of 10mM ammonium formate and acetonitrile in the ratio of 50:50v/v at an isocratic flow rate of 1ml/min. The detection is carried out at 220nm. Results: The calibration curve is linear in the concentration range of 5-25 μg/ml. The method is statistically validated for its linearity, precision, accuracy, stability and specificity as per ICH Q2R1 guidelines and the method is found to be robust. The LOD and LOQ values were found to be 0.748 and 2.62 μg/ml respectively. Conclusion: Hence the proposed method was found to be precise, accurate, LCMS compatible and can easily adaptable for quality control of paroxetine in dosage forms , biological fluids, dissolution studies.
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