HPLC测定双唑泰阴道泡腾片三组分的含量

Determination the content of metronidazole,clotrimazole and chlorhexidine acetate effervescent tablets by HPLC

目的建立HPLC法测定双唑泰阴道泡腾片三组分的含量。方法采用W aters XTerraR○RP18(250mm×4.6mm,5μm),以甲醇-水-三乙胺(70∶30∶0.3)(含庚烷磺酸钠10mmol.L-1,用磷酸调pH值至4.0)为流动相,检测波长260nm。结果甲硝唑、克霉唑和醋酸氯己定分别在0.05～0.5mg.mL-1、0.04～0.4mg.mL-1和2～20μg.mL-1浓度范围内,与峰面积呈良好的相关性(r=0.9999、r=0.9999和r=0.9996),平均回收率为100.3%,RSD为0.38%(n=9);100.3%,RSD为0.48%(n=9);100.3%,RSD为0.67%(n=9)。结论该方法简便、准确、重现性好,可作为该制剂的质量控制标准。

OBJECTIVE To establish a method for the determination of metronidazole, clotrimazole and chlorhexidine acetate effervescent tablets by HPLC. METHODS A Waters XTerra RP18 （250mm × 4.6mm,5μm） was used, the mobile phase was methanol-water-Triethlamine （70： 30： 0. 3）（ Sodium Heptanesulfonate 10mmol · L^-1, pH4.0） , the UV detection wassetat 260nm. RESULTS Metronidazole, clotrimazole and chlorhexidine acetate was respectively liner in the range of 0.05 mg· mL^-1 -0. 5mg· mL^-1（ r = 0. 9999）,0.04mg· mL^-1- 0. 4mg· mL^-1 （ r = 0. 9999） and 2μg · mL^-1 - 20μg· mL^-1 （ r = 0. 9996 ）, the average recovery of metronidazole was 100. 3% with RSD 0.38% （ n = 9） ; of clotrimazole was 100. 3% with RSD 0.48% （ n = 9） ; of chlorhexidine acetate was 100. 3 % with RSD 0.67% （ n = 9） o CONCLUSION The method was simple, accurate and reliable, and it is suitable for the determination of the preparation.