Girgis E H
Quality Department, Advanced Biochemical Industries, Glaxo Company, El-Salam City, Cairo, Egypt.
J Pharm Sci. 1993 May;82(5):503-5. doi: 10.1002/jps.2600820514.
A reversed-phase ion-pair high-performance liquid chromatographic separation was developed for identification and quantitation of papaverine drug congeners, namely papaverine (1), moxaverine (2), drotaverine (3), and ethaverine (4) hydrochlorides. A synthetic reference mixture of the four congeners in the range 1-4 micrograms showed good separation. With a reference standard (codeine phosphate), the relative retention times to codeine were 1.356, 1.984, 2.46, and 2.91 (mean of six) for 1, 2, 3, and 4, respectively. Good linearity was obtained in the quantitation of 1 and 2 in the range 1-2 micrograms [correlation coefficient (r), 0.9978 and 0.9997, respectively] and 3 and 4 in the range 2-4 micrograms, (r, 0.9998 and 0.9991, respectively). Analysis of some commercial dosage forms containing one of these congeners showed good recovery with sufficient accuracy and precision. The method was sensitive and permitted the use of small sample sizes or unit doses.
建立了一种反相离子对高效液相色谱分离方法，用于鉴定和定量罂粟碱药物同系物，即罂粟碱（1）、莫沙维林（2）、屈他维林（3）和盐酸乙罂粟碱（4）。四种同系物在1 - 4微克范围内的合成参考混合物显示出良好的分离效果。以对照标准品（磷酸可待因）计，1、2、3和4相对于可待因的相对保留时间分别为1.356、1.984、2.46和2.91（六次测量的平均值）。在1 - 2微克范围内对1和2进行定量时，以及在2 - 4微克范围内对3和4进行定量时，均获得了良好的线性关系，相关系数（r）分别为0.9978和0.9997，以及0.9998和0.9991。对含有这些同系物之一的一些市售剂型进行分析，结果显示回收率良好，具有足够的准确度和精密度。该方法灵敏，允许使用小样本量或单位剂量。
