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建立1%克林霉素磷酸酯软膏剂高效液相色谱测定法,研究该制剂的稳定性,为进一步开发此药奠定基础。HPLC仪,ShimadzuLC-9A;色谱柱为150mm×6mmID(ODS,5μm);流动相为乙睛-磷酸盐缓冲液(27:73);检测波长210nm。结果:工作曲线方程Y=-57.18+1364.48X,r=0.9997(n=6);回收率100.4%;天内天间的相对标准差分别为1.24%、1.80%。在40℃加速试验3个月,3个批号标示量含量分别为101.7%、105.2%及106.0%。强光照射10d,3个批号的标示量含量分别为101.7%、104.1%及105.3%。结论:建立的HPLC法具有简便、快速、准确度高及重现性好等优点;该软膏剂对强光照射不敏感,室温保存稳定,值得开发。
The establishment of 1% clindamycin phosphate ointment high performance liquid chromatography, study the stability of the preparation, and lay the foundation for the further development of this drug. HPLC instrument, Shimadzu LC-9A; column 150 mm × 6 mmID (ODS, 5 μm); mobile phase was acetonitrile-phosphate buffer (27:73); detection wavelength was 210 nm. Results: The equation of working curve was Y = -57.18 + 1364.48X, r = 0.9997 (n = 6). The recovery rate was 100.4%. The relative standard deviations were 1.24% and 1.80% respectively. Accelerated test at 40 ℃ for 3 months showed that the contents of the three lot numbers were 101.7%, 105.2% and 106.0% respectively. After 10 days of intense light irradiation, the labeled contents of the three batches were 101.7%, 104.1% and 105.3% respectively. Conclusion: The established HPLC method has the advantages of simple, rapid, high accuracy and good reproducibility. The ointment is insensitive to strong light irradiation and stable at room temperature, which deserves to be developed.