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目的 建立泰唑洗液中甲硝唑和醋酸氯己啶含量的HPLC测定方法。方法 采用C18柱 (2 5 0mm× 4 .6mm ,10 μm ) ,流动相为甲醇 乙腈 三乙胺缓冲液 (0 .0 5mol·mL-1,用磷酸调节 pH至 2 .5 ) (30∶ 30∶ 4 0 ,v/v ) ,内标物为醋酸泼尼松。流速为 1.0mL·min-1,检测波长为 2 5 4nm。结果 线性范围 :甲硝唑 32～ 12 8μg·mL-1(r =0 .99996 ) ,醋酸氯己啶 2 0～80 μg·mL-1(r =0 .99997)。精密度 :日内及日间RSD为 :甲硝唑 0 .12 % (n =6 )和 0 .32 % (n =5 ) ;醋酸氯己啶 0 .18% (n =6 )和 0 .35 % (n =5 )。平均回收率甲硝唑为 10 0 .4 % (RSD =0 .19%n =5 ) ,醋酸氯己啶为 99.94 % (RSD= 0 .2 0 % ,n =5 )。结论 本法简便 ,快速 ,准确 ,可用于该制剂的质量控制
Objective To establish a HPLC method for the determination of metronidazole and hexachloroacetate in taezole lotion. Methods C18 column (250 mm × 4.6 mm, 10 μm) was used. The mobile phase was methanol-acetonitrile-triethylamine buffer (0.050 mol·L -1, adjusted to pH 2.5 with phosphoric acid) (30:30 : 40, v / v) and the internal standard is prednisone acetate. Flow rate of 1.0mL · min-1, detection wavelength of 254nm. Results The linear range of metronidazole 32 ~ 128μg · mL-1 (r = 0.99996), chlorohexidine acetate 20 ~ 80 μg · mL-1 (r = 0.99997). Precision: Intra-day and inter-day RSD was 0.12% (n = 6) and 0.32% (n = 5) for metronidazole, 0.18% (n = 6) and 0.35 for chlorhexidine acetate % (n = 5). The mean recovery was 10 0.4% for metronidazole (RSD = 0.19% n = 5) and 99.94% for chlorohexidine acetate (RSD = 0.2%, n = 5). Conclusion This method is simple, rapid and accurate and can be used for the quality control of this preparation