药学与临床研究
藥學與臨床研究
약학여림상연구
PHARMACEUTICAL AND CLINICAL RESEARCH
2014年
5期
419-421
,共3页
双唑泰栓%优化%HPLC 法
雙唑泰栓%優化%HPLC 法
쌍서태전%우화%HPLC 법
Metronidazole%Cclotrimazole and chlorhexidine acetate suppositories%Optimization%HPLC
目的：对双唑泰栓中3组分含量测定方法进行改进及优化。方法：采用 HPLC 法测定双唑泰栓中甲硝唑、克霉唑及醋酸氯己定的含量，以 CAPCELL PAK C18为色谱柱，甲醇-水-三乙胺（70∶30∶0.3）（含庚烷磺酸钠10 mmol·L-1,用磷酸调节 pH 值至6.0）为流动相，流速：1.0 mL· min-1，柱温：30℃，检测波长：260 nm；进样量：20μL。结果：采用 HPLC 法，3个成分能很好分离，甲硝唑在53.2～425.6μg·mL-1范围内浓度与峰面积呈良好的线性关系，r=0.9999，平均回收率为99.69%，RSD 为1.32%；克霉唑在70.78~326.24μg·mL-1范围内浓度与峰面积呈良好的线性关系， r=0.9999，平均回收率为99.64%，RSD 为1.27%；醋酸氯己定在1.87~14.93μg·mL-1范围内浓度与峰面积呈良好的线性关系，r=0.9998，平均回收率为99.92%，RSD 为1.45%。结论：优化的方法能提高测定方法的精密度和准确性，从而更好地控制产品质量。
目的：對雙唑泰栓中3組分含量測定方法進行改進及優化。方法：採用 HPLC 法測定雙唑泰栓中甲硝唑、剋黴唑及醋痠氯己定的含量，以 CAPCELL PAK C18為色譜柱，甲醇-水-三乙胺（70∶30∶0.3）（含庚烷磺痠鈉10 mmol·L-1,用燐痠調節 pH 值至6.0）為流動相，流速：1.0 mL· min-1，柱溫：30℃，檢測波長：260 nm；進樣量：20μL。結果：採用 HPLC 法，3箇成分能很好分離，甲硝唑在53.2～425.6μg·mL-1範圍內濃度與峰麵積呈良好的線性關繫，r=0.9999，平均迴收率為99.69%，RSD 為1.32%；剋黴唑在70.78~326.24μg·mL-1範圍內濃度與峰麵積呈良好的線性關繫， r=0.9999，平均迴收率為99.64%，RSD 為1.27%；醋痠氯己定在1.87~14.93μg·mL-1範圍內濃度與峰麵積呈良好的線性關繫，r=0.9998，平均迴收率為99.92%，RSD 為1.45%。結論：優化的方法能提高測定方法的精密度和準確性，從而更好地控製產品質量。
목적：대쌍서태전중3조분함량측정방법진행개진급우화。방법：채용 HPLC 법측정쌍서태전중갑초서、극매서급작산록기정적함량，이 CAPCELL PAK C18위색보주，갑순-수-삼을알（70∶30∶0.3）（함경완광산납10 mmol·L-1,용린산조절 pH 치지6.0）위류동상，류속：1.0 mL· min-1，주온：30℃，검측파장：260 nm；진양량：20μL。결과：채용 HPLC 법，3개성분능흔호분리，갑초서재53.2～425.6μg·mL-1범위내농도여봉면적정량호적선성관계，r=0.9999，평균회수솔위99.69%，RSD 위1.32%；극매서재70.78~326.24μg·mL-1범위내농도여봉면적정량호적선성관계， r=0.9999，평균회수솔위99.64%，RSD 위1.27%；작산록기정재1.87~14.93μg·mL-1범위내농도여봉면적정량호적선성관계，r=0.9998，평균회수솔위99.92%，RSD 위1.45%。결론：우화적방법능제고측정방법적정밀도화준학성，종이경호지공제산품질량。
Objective: To optimize the determination method for three components in metronidazole, clotrimazole and chlorhexidine acetate suppositories. Methods: An optimizative HPLC was used to deter-mine three components in metronidazole, clotrimazole and chlorhexidine acetate suppositories. The CAPCELL PAK C18 column (250 mm×4.6 mm, 5 μm) was used. The mobile phase consisted of methanol-water-triethy-lamine (70∶30∶0.3) (consisted sodium heptanesulphonate 10 mmol·L-1, adjusted by phosphoric acid to pH 6.0), The flow rate was 1.0 mL·min-1 and the column temperature was 30 ℃. The UV detection wavelength was set at 260 nm. Results: Optimizing studies showed that the three components had good resolutions. The linear ranges were 53.2~425.6 μg·mL-1 for metronidazole, 70.78~326.24 μg·mL-1 for clotrimazole and 1.87~14.92 μg·mL -1 for chlorhexidine acetate with the correlation coefficient 0.9999, 0.9999 and 0.9998, respectively. The average recoveries were 99.69% with 1.32.% , 99.64% with 1.27% and 99.92% with 1.45% (n=9). Conclusions: The optimized method can improve the precision and accuracy of the determi-nation method to achieve better quality control.
