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采用导数紫外分光光度法和高效液相色谱法对片剂中的氨溴索进行定量测定。

Quantitative determination of ambroxol in tablets by derivative UV spectrophotometric method and HPLC.

作者信息

Dinçer Zafer, Basan Hasan, Göger Nilgün Günden

机构信息

Faculty of Pharmacy, Department of Analytical Chemistry, Gazi University, Etiler, Ankara 06330, Turkey.

出版信息

J Pharm Biomed Anal. 2003 Apr 1;31(5):867-72. doi: 10.1016/s0731-7085(02)00664-7.

DOI:10.1016/s0731-7085(02)00664-7
PMID:12684099
Abstract

A derivative UV spectrophotometric method for the determination of ambroxol in tablets was developed. Determination of ambroxol in tablets was conducted by using first-order derivative UV spectrophotometric method at 255 nm (n = 5). Standards for the calibration graph ranging from 5.0 to 35.0 microg/ml were prepared from stock solution. The proposed method was accurate with 98.6+/-0.4% recovery value and precise with coefficient of variation (CV) of 1.22. These results were compared with those obtained by reference methods, zero-order UV spectrophotometric method and reversed-phase high-performance liquid chromatography (HPLC) method. A reversed-phase C(18) column with aqueous phosphate (0.01 M)-acetonitrile-glacial acetic acid (59:40:1, v/v/v) (pH 3.12) mobile phase was used and UV detector was set to 252 nm. Calibration solutions used in HPLC were ranging from 5.0 to 20.0 microg/ml. Results obtained by derivative UV spectrophotometric method was comparable to those obtained by reference methods, zero-order UV spectrophotometric method and HPLC, as far as ANOVA test, F(calculated) = 0.762 and F(theoretical) = 3.89, was concerned.

摘要

建立了一种用于测定片剂中氨溴索的导数紫外分光光度法。采用一阶导数紫外分光光度法在255 nm处(n = 5)对片剂中的氨溴索进行测定。由储备液制备校准曲线的标准品,浓度范围为5.0至35.0μg/ml。所提出的方法准确,回收率为98.6±0.4%,精密度良好,变异系数(CV)为1.22。将这些结果与参考方法(零阶紫外分光光度法和反相高效液相色谱法(HPLC))获得的结果进行比较。使用反相C(18)柱,流动相为磷酸盐缓冲液(0.01 M)-乙腈-冰醋酸(59:40:1,v/v/v)(pH 3.12),紫外检测器设定为252 nm。HPLC中使用的校准溶液浓度范围为5.0至20.0μg/ml。就方差分析测试而言,导数紫外分光光度法获得的结果与参考方法(零阶紫外分光光度法和HPLC)获得的结果具有可比性,F(计算值)= 0.762,F(理论值)= 3.89。

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