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Development and Validation of a New HPLC Method for the Determination of Gabapentin

机译:新型高效液相色谱法测定加巴喷丁的研制与验证

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摘要

A simple HPLC method was developed and validated for quantitation of gabapentin in pure form. The HPLC separation was achieved on a C18 5 μm Waters column (150 mm × 4.6 mm) using a mobile phase of methanol - potassium dihydrogen orthophosphate solution (20:80, v/v) containing 10% NaOH to adjust pH6.2 at a flow rate of 1.0 ml/min. The UV detector was operated at 275 nm. The method was validated for specificity, linearity, precision, accuracy, robustness and limit of quantitation. The degree of linearity of the calibration curves, the percent recoveries, limit of detection and quantitation for the HPLC method were determined. The method was found to be simple, specific, precise, accurate, and reproducible.
机译:开发了一种简单的HPLC方法,并验证了该方法可用于定量纯化加巴喷丁。 HPLC分离是在C18 5μmWaters色谱柱(150 mm×4.6 mm)上进行的,使用的是甲醇-正磷酸二氢钾溶液(20:80,v / v)的流动相,在10℃下调节pH6.2。流速为1.0 ml / min。 UV检测器在275nm下操作。验证了该方法的特异性,线性,精密度,准确性,稳健性和定量限。确定了HPLC方法的校准曲线的线性度,回收率,检测限和定量限。发现该方法简单,专一,精确,准确且可重复。

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