高效液相色谱法同时测定克洛己新干混悬剂中头孢克洛和盐酸溴己新的含量(1)
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[摘要] 目的 建立一种高效液相色谱分析方法，用于同时测定克洛己新干混悬剂中两种成分头孢克洛和盐酸溴己新的含量。 方法 以CAPCELL PAK C18 MGⅡ(5 μm，4.6 mm × 250 mm)为色谱柱，0.005 mol/L四丁基氢氧化铵溶液(用磷酸调节pH 3.2)-甲醇(45∶55)为流动相；用双波长同时检测，波长为254、249 nm；流速为1.0 mL/min，柱温为30℃。 结果 通过一次进样同时测定了克洛己新干混剂中两种组分的含量，头孢克洛进样量在1.602～16.020 μg范围内进样量与峰面积呈良好线性关系，r = 0.996 1，样品平均加样回收率为97.6%(n = 6)，RSD为0.80%；盐酸溴己新进样量在0.080 24～0.802 40 μg范围内进样量与峰面积呈良好线性关系，r = 0.999 2，样品平均加样回收率为99.0%(n = 6)，RSD为1.40%。 结论 本方法简便、准确、重复性好，可用于克洛己新干混悬剂中头孢克洛和盐酸溴己新的含量测定。
[关键词] 头孢克洛；盐酸溴己新；克洛己新干混悬剂；双波长；高效液相色谱
[中图分类号] R286.0 [文献标识码] A [文章编号] 1673-7210(2012)01(c)-0114-03
Simultaneous determination of Cefaclor and Bromhexine Hydrochloride in Cefaclor and Bromhexine Hydrochloride for Suspension by HPLC
ZHU Youlin1 TAI Shunzhang2
1.Maternity and Child Care Hospital of Yancheng City, Jiangsu Province, Yancheng 224007, China; 2.Institute for Drug Control of Yanchen City, Jiangsu Province, Yancheng 224002, China
[Abstract] Objective To establish a method for content determination of Cefaclor and Bromhexine Hydrochloride in Cefaclor and Bromhexine Hydrochloride for Suspension by high-performance liquid chromatography (HPLC). Methods The method was adopted for the determination with CAPCELL PAK C18 MGⅡ(5 μm, 4.6 mm × 250 mm) as chromatographic column, 0.005 mol/L Tetrabutylammonium hydroxide solution (adjust pH to 3.2 by Phosphoric acid) - Methanol (45∶55) as mobile phase; dual wavelength (254 nm, 249 nm) determine were used simultaneously. The flow rate was 1.0 mL/min and the column temperature was at 30℃. Results Cefaclor and Bromhexine Hydrochloride in Cefaclor and Bromhexine Hydrochloride for Suspension were determined simultaneously by a sample test. The sample amount had good linear relation with peak area with the Cefaclor was 1.602-16.020 μg (r = 0.996 1)， with the sample recovery was 97.6% (RSD = 0.80%, n = 6)； while the sample amount had good linear relation with peak area with the Bromhexine Hydrochloride was 0 ......
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