Gupta Abhay, Ciavarella Anthony B, Sayeed Vilayat A, Khan Mansoor A, Faustino Patrick J
Division of Product Quality Research, Office of Pharmaceutical Science, Food and Drug Administration, Life Science Building 64, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
J Pharm Biomed Anal. 2008 Jan 7;46(1):181-6. doi: 10.1016/j.jpba.2007.08.023. Epub 2007 Sep 1.
A simple isocratic reversed-phase HPLC method was developed and validated for the analysis of dissolution samples of gabapentin tablets and capsules. Separation of gabapentin from its major degradation impurity, 3,3-pentamethylene-4-butyrolactam was achieved on a Phenomenex Luna Cyano column using a methanol-acetonitrile-20 mM KH(2)PO(4) (pH 2.2) (5:5:90, v/v/v) mobile phase. The compounds were eluted isocratically at a flow rate of 1.25 mL/min. Both compounds were analyzed with UV detection at 210 nm. The method was validated according to USP Category I requirements for gabapentin. The validation characteristics included accuracy, precision, linearity, range, specificity and limit of quantitation. Robustness testing was also conducted to evaluate the effect of minor changes to the chromatographic system and to establish appropriate system suitability parameters. Validation acceptance criteria were met in all cases. This method was used successfully for the quality assessment of five gabapentin drug products.
建立了一种简单的等度反相高效液相色谱法，并对其进行了验证，用于分析加巴喷丁片和胶囊的溶出度样品。在Phenomenex Luna氰基柱上，使用甲醇-乙腈-20 mM KH(2)PO(4)（pH 2.2）（5:5:90，v/v/v）流动相，实现了加巴喷丁与其主要降解杂质3,3-亚戊基-4-丁内酰胺的分离。化合物以1.25 mL/min的流速等度洗脱。两种化合物均在210 nm处进行紫外检测。该方法根据美国药典对加巴喷丁的I类要求进行了验证。验证特性包括准确度、精密度、线性、范围、特异性和定量限。还进行了稳健性测试，以评估色谱系统微小变化的影响，并建立适当的系统适用性参数。所有情况下均符合验证验收标准。该方法成功用于五种加巴喷丁药品的质量评估。
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