收稿日期 - 中国药物评价.doc

HPLC法测定复方克霉唑乳膏中氯甲酚的含量 彭博 董斌 （大连市药品检验所，大连 116021） [摘要] 目的：。方法：使用aters Xbridge-C18 (4.6×250mm，5μm)色谱柱以0.05mol/L磷酸二氢钾溶液（用mol/L氢氧化钾溶液调节pH值为5.7±0.05）为流动相；检测波长为2nm；流速为1.0ml/min。结果：在10.407g/ml~31.222μg/ml(r=0.9990)范围内线性关系良好，平均回收率为%（RSD=0.75%，n=。结论：该方法准确，重复性好，可用于的质量控制。 [关键词] HPLC法；质量标准 etermination of Chlorocresol in Compound Clotrimazole Cream by HPLC Peng Bo Dong Bin (Dalian Institute for Drug Control, Dalian 116021) [Abstract] Objective:To establish an HPLC method for determination of Chlorocresol in Compound Clotrimazole Cream. Methods: HPLC method was carried on with a Waters Xbridge-C18 (4.6×250 mm,5 μm)column, using a gradient method for mobilephase, a mixture of a 0.05 mol/L potassium dihydrogen phosphate solution(pH adjusted to 5.7 with 2mol/L potassium hydroxide solution)as the mobile phase A, acetonitrile-methanol (1:1) as the mobile phase B. Detection wavelength was set at 280 nm, the flow rate was 1.0mL/min, and the column temperature was 35℃.ResultsResult:The calibration curves were linear in the range of 10.407μg/ml~31.222μg/ml(r=0.9990) for Chlorocresol. The average recovery rate was 99.5% with RSD 0.75%(n＝). Conclusion:The method is convenient, accrate with a good reproducibility, and suitable for quality control of Compound Clotrimazole Cream. [Key Words] Chlorocresol, Chlorocresol, HPLC,Quality control 复方克霉唑乳膏是一种消炎、抗菌的外用复合制剂，适用于接触性皮炎、皮肤浅表真菌感染：如手癣、股癣、体癣、牛皮癣等。氯甲酚是一种酚类衍生物消毒剂，不但能损害菌体细胞膜，使菌体内含物逸出和蛋白质变性，呈杀菌作用，而且还可通过抑制细菌脱氢酶和氧化酶等酶的活性，呈现抑菌作用[1]。乳膏中有大量的甘油和碳水化合物，这些东西容易滋生细菌，氯甲酚作为防霉抗菌剂，可用于的质量控制。 1 Waters e2695高效液相色谱仪，Waters 2489紫外检测器，，Sartorius BP211D型电子天平 氯甲酚对照品（中国食品药品检定研究院提供，批号为）由有限公司提供，批号为、、。乙腈为色谱纯，水为二次蒸馏水，其余试剂均为分析纯。 2 方法与结果 2.1色谱条件与系统适用性试验 色谱柱：aters Xbridge-C18（4.6×250mm，5μm）；以0.05mol/L磷酸二氢钾溶液（70:30）（用mol/L氢氧化钾溶液调节pH值为5.7±0.05）为流动相，流速：1.0mLmin；检测波长：2nm；柱温：35℃；进样量：μL。。 流动相A(%) 流动相B(%) 0 45 55 8 45 55 8.1 30 70 16 30 70 16.1 45 55 22 45 55 表1 梯度洗脱比例 2.2 溶液制备 2..1 供试品溶液制备取本品约1g精密称定，置50ml量瓶中，加甲醇28ml置50℃水浴中加热振摇使溶化，取出强烈振摇5分钟，加水12ml振摇，放冷，用