New reversed-phase high-performance liquid chromatography method has been developed and validated for the identification of impurity in calcium orotatedihydrate (CaOD) drug. The developed method has been achieved superior resolution between the impurity and CaOD using Alltima C-18 column (250 X 4.6 mm, 5 μm). The method has been established by isocratic mobile phase comprising of 0.01 mol/L of potassium dihydrogen orthophosphate, pH adjusted to 2.7 with orthophosphoric acid and acetonitrile in a ratio of 98:2 v/v. The eluted impurity at the retention time of 6.02 min has so far not been reported in earlier methods of analysis. According to International council for harmonization guidelines, the method has been validated with respect to accuracy, precision, specificity, linearity, range, robustness, system suitability, limit of detection and limit of quantification. The percentage recovery of CaOD and uracil is found in the range between 98% and 102%. The linearity data has shown that the method is found to be linear for CaOD and uracil from 25% to 150% level and the correlation coefficient is found to be more than 0.999. The reported method is not affected by small but deliberate changes in the parameters of the method.

中文翻译：

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反相高效液相色谱法对仿制药乳清酸钙进行杂质分析

已开发并验证了新的反相高效液相色谱方法，用于鉴定二水乳清酸钙 (CaOD) 药物中的杂质。所开发的方法使用 Alltima C-18 色谱柱（250 X 4.6 mm，5 μm）在杂质和 CaOD 之间实现了卓越的分辨率。该方法是通过等度流动相建立的，流动相由 0.01 mol/L 的正磷酸二氢钾组成，用正磷酸和乙腈以 98:2 v/v 的比例将 pH 调节至 2.7。在 6.02 分钟的保留时间洗脱的杂质迄今尚未在早期的分析方法中报告。根据国际协调委员会的指导方针，该方法已在准确度、精密度、特异性、线性、范围、稳健性、系统适用性、检测限和定量限。CaOD 和尿嘧啶的回收率在 98% 到 102% 之间。线性数据表明，发现该方法对 CaOD 和尿嘧啶在 25% 至 150% 的水平上呈线性，相关系数大于 0.999。报告的方法不受方法参数的微小但有意更改的影响。