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首页> 外文期刊>Journal of liquid chromatography and related technologies >QUALITY CONTROL AND DRUG DISSOLUTION STUDIES OF PHARMACEUTICAL PREPARATIONS CONTAINING CERIVASTATIN SODIUM BY MEANS OF RP-HPLC
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QUALITY CONTROL AND DRUG DISSOLUTION STUDIES OF PHARMACEUTICAL PREPARATIONS CONTAINING CERIVASTATIN SODIUM BY MEANS OF RP-HPLC

机译：RP-HPLC法测定包含西立伐他汀钠的药物制剂的质量控制和药物溶出度

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摘要

A novel, rapid, sensitive, accurate, and simple isocratic HPLC assay was developed to determine cerivastatin in pharmaceutical dosage forms and human serum. The proposed method was conducted using a reverse phase technique, UV monitoring at 232 nm, and losartan potassium as an internal standard. The detector response was linear in the range of 25-10000 ng/mL. This compound is well separated with a Waters C_(180 column (150 x 4.6 mm; 5 urn particle size) by using a mobile phase consisting of a mixture of acetonitrile:0.01 M KH_2PO_4 adjusted to pH 3.1 with H_3PO_4 (35 :65 v/v), at a flow rate of l.0mL/min. The limit of detection and the limit of quantitation of the procedure were 0.62 ng/mL and 2.07 ng/mL for cerivastatin, respectively. The retention time was 6.90 min for cerivastatin and 8.78 min for internal standard. No interferences were observed from tablet additives and the applicability of the method was examined by analyzing tablets containing cerivastatin. This method was also applied, without any interference from the excipients, for the determination of cerivastatin in drug dissolution studies. The proposed method was successfully applied to the analysis of cerivastatin in human serum.
机译：开发了一种新颖，快速，灵敏，准确和简单的等度HPLC测定法，以测定药物剂型和人血清中的西立伐他汀。所提出的方法是使用反相技术，232 nm的紫外线监测以及氯沙坦钾作为内标进行的。检测器响应在25-10000 ng / mL范围内呈线性。通过使用由乙腈：0.01 M KH_2PO_4调节至pH 3.1和H_3PO_4（35:65 v /）的混合物组成的流动相，用Waters C_（180柱（150 x 4.6 mm; 5 n粒径））将该化合物充分分离。 v），流速为1.0mL / min，西立伐他汀的检出限和定量限分别为0.62 ng / mL和2.07 ng / mL，西立伐他汀和西立他汀的保留时间为6.90分钟内标为8.78分钟，未观察到片剂添加剂的干扰，并且通过分析含有西立伐他汀的片剂来检验该方法的适用性，该方法也可在不影响辅料的情况下用于药物溶解研究中西立伐他汀的测定。该方法成功地用于人血清中西立伐他汀的分析。

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