HPLC法同时测定复方锌布颗粒剂中3种组分的含量

HPLC simultaneous determination of three components in compound zinc gluconate and ibuprofen granules

目的:建立复方锌布颗粒剂中葡萄糖酸锌、布洛芬和马来酸氯苯那敏含量同时测定的HPLC方法。方法:采用C18色谱柱,以含0.40%三乙胺的0.04mol.L-1KH2PO4溶液(pH=2.60)-乙腈(65:35)为流动相A,以含0.40%三乙胺的0.04mol.L-1KH2PO4溶液(pH=2.60)-乙腈(50:50)为流动相B,梯度洗脱,检测波长为215nm。结果:葡萄糖酸锌线性范围为0.09638～3.084g.L-1,马来酸氯苯那敏和布洛芬的线性范围均为0.006250～0.2000g.L-1。方法回收率为98.0%～101.7%,日内及日间精密度RSD小于1.0%。结论:本方法同时测定复方锌布颗粒剂中3种组分的含量,快速、简便、准确,可用于该制剂的质量控制。

Objective：To establish an RP-HPLC method for simultaneous determination of zinc gluconate,ibuprofen and chlorphenamine maleate in compound zinc gluconate and ibuprofen granules.Methods：The RP-HPLC method was used.The separation was performed on ODS column by gradient elution with mobile phase of A ／[0.04 mol·L-1KH2PO4（ contained 0.4% triethylamine,adjusted to pH 2.60 with phosphoric acid ）-acetonitrile（65：35）／] and B／[0.04 mol·L-1KH2PO4（ contained 0.4% triethylamine,adjusted to pH 2.60 with phosphoric acid ）-acetonitrile（50：50）／],the detection wavelength was set at 215 nm.Results：The calibration curve was linear over the range of 0.09638-3.084 g·L-1 for zinc gluconate and 0.006250-0.2000 g·L-1 for ibuprofen and chlorphenamine maleate.The recovery was 98.0%-101.7%.The RSDs for within day and between days were all less then 1.0%.Conclusion：The method can be easily employed with high precision and accuracy for simultaneous determination of three components in compound zinc gluconate and ibuprofen granules,and can be used for the quality control in production process of the granules.