论文部分内容阅读
目的:建立一种能用于注射用乳糖酸阿奇霉素中有关物质和含量控制的HPLC方法。方法:采用CAPCELL PAK C18(MGⅡ)柱(150 mm×4.6 mm,5μm),柱温30℃,流动相为磷酸盐缓冲液(0.05 mol.L-1磷酸氢二钾溶液,磷酸调pH至8.4±0.1)-乙腈(45∶55),流速1.0 ml.min-1,检测波长210 nm。结果:有关物质与主成分阿奇霉素能达到基线分离;酸根对有关物质的测定无影响;阿奇霉素在0.469 0～1.407 0 mg.ml-1范围内线性关系良好(r=0.999 5),平均回收率98.6%(n=6),RSD为0.4%。结论:该法简便,准确,其他组分不干扰测定,可用于本品的质量控制。
OBJECTIVE: To establish a HPLC method that can be used for the control of related substances and contents in azithromycin lactobionate for injection. METHODS: CAPCELL PAK C18 column (150 mm × 4.6 mm, 5 μm) was used. The column temperature was 30 ℃. The mobile phase consisted of phosphate buffer (0.05 mol·L -1 dipotassium hydrogen phosphate solution, phosphoric acid adjusted to pH 8.4 ± 0.1) -acetonitrile (45:55) at a flow rate of 1.0 ml.min-1 at a detection wavelength of 210 nm. Results: Azithromycin was able to achieve the baseline separation of the substance and the main component; the acid radical had no effect on the determination of related substances; the linearity of azithromycin in the range of 0.469 0-1.407 0 mg.ml-1 was good (r = 0.999 5) and the average recovery was 98.6 % (n = 6), RSD 0.4%. Conclusion: The method is simple and accurate, the other components do not interfere with the determination, can be used for the quality control of this product.