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首页> 外文期刊>Журнал аналитической химии >SENSITIVE AND SELECTIVE SPECTROPHOTOMETRY METHODS FOR THE DETERMINATION OF PHENIRAMINE MALEATE IN BULK DRUG AND IN ITS FORMULATIONS USING SODIUM HYPOCHLORITE
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SENSITIVE AND SELECTIVE SPECTROPHOTOMETRY METHODS FOR THE DETERMINATION OF PHENIRAMINE MALEATE IN BULK DRUG AND IN ITS FORMULATIONS USING SODIUM HYPOCHLORITE

机译:次氯酸钠灵敏和选择性分光光度法测定散装毒品及其制剂中的马来苯丙胺含量。

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摘要

Two simple, selective and sensitive spectrophotometric methods are described for the determination of phe-niramine maleate (РАМ) in pure and dosage forms. The method is based on the reaction of РАМ with hypochlorite in the presence of Kolthoff buffer (phosphate-borate) of pH 7.0 to form the chloro derivative of РАМ, destruction of the excess hypochlorite by nitrite ion (the chloro derivative of drug is unaffected under the optimized conditions) followed by the oxidation of iodide with the chloro derivative of РАМ to iodine (ij) which is either measured directly at 355 (method A) or reacted with starch to form a blue chromogen measurable at 590 nm (method B). The optimum conditions that affect the reaction were ascertained, and under these conditions linear relationship was obtained in the concentration ranges of 2—50 and 1—25 ug/mL РАМ in methods Aand B, respectively. The calculated molar absorptivity values are 7.26 x 103and 1.28x 10~4 L/mol cm for method A and method B, respectively. Sandell's sensitivity values, limits of detection (LOD) and quantification (LOQ) are calculated as per ICH guidelines. The proposed methods were applied successfully to the determination of РАМ in tablets and injection with good accuracy and precision and without interferences from common additives. The results obtained by the proposed methods were compared favourably with those of the reference method. The accuracy and reliability of the proposed methods were further checked by recovery studiesvia standard addition procedure.
机译:描述了两种简单,选择性和灵敏的分光光度法测定纯和剂型马来酸邻苯二胺。该方法基于РАМ与次氯酸盐在pH 7.0的Kolthoff缓冲液(硼酸磷酸盐)存在下反应形成РАМ的氯衍生物,亚硝酸根离子破坏过量的次氯酸盐(药物的氯衍生物在最佳条件),然后用РАМ的氯衍生物将碘化物氧化为碘(ij),可以直接在355(方法A)处测量,也可以与淀粉反应形成在590 nm处可测量的蓝色色原(方法B)。确定了影响反应的最佳条件,并且在这些条件下,在方法A和B中分别在2-50和1-25 ug / mLРАМ的浓度范围内获得线性关系。方法A和方法B的摩尔吸光度值分别为7.26 x 103和1.28x 10〜4 L / mol cm。根据ICH准则计算Sandell的灵敏度值,检测限(LOD)和定量(LOQ)。所提出的方法已成功地应用于片剂和注射剂中РАМ的测定,准确度和精密度高,并且不受普通添加剂的干扰。通过提议的方法获得的结果与参考方法的结果进行了比较。通过标准添加程序进行回收率研究,进一步验证了所提出方法的准确性和可靠性。

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