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高效液相色谱法测定缓释片制剂中氯苯扎利二钠的含量

High performance liquid chromatographic method for the determination of lobenzarit disodium in a sustained release tablet formulation.

作者信息

Paneque A, Torres A I, Camacho M A

机构信息

Center of Pharmaceutical Chemistry, Havana, Cuba.

出版信息

Arzneimittelforschung. 1998 Aug;48(8):832-5.

PMID:9748712
Abstract

A rapid and simple high performance liquid chromatographic method is described and validated for the determination of lobenzarit disodium (CAS 64808-48-6) in a sustained release tablet formulation. The calibration graph was linear over the range 20-105 micrograms/ml. The sensitivity (discriminator capacity) was 2.079 micrograms/ml. The coefficient of variations for repeatability and reproducibility were less than 1.60% and 1.30%, respectively. The accuracy of the method did not depend on lobenzarit concentration in tablets. The mean recovery was found to be 100.62%. The method was selective, even when degradation products were present.

摘要

本文描述并验证了一种快速简便的高效液相色谱法,用于测定缓释片剂制剂中的洛苯扎替二钠(CAS 64808-48-6)。校准曲线在20-105微克/毫升范围内呈线性。灵敏度(鉴别能力)为2.079微克/毫升。重复性和重现性的变异系数分别小于1.60%和1.30%。该方法的准确性不取决于片剂中洛苯扎替的浓度。平均回收率为100.62%。该方法具有选择性,即使存在降解产物时也是如此。

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