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目的:建立复方左炔诺孕酮片和复方左炔诺孕酮滴丸中炔雌醇和左炔诺孕酮含量测定的高效液相色谱法,考察复方左炔诺孕酮片及滴丸的含量均匀度。方法:采用Waters Symmetry300TM C18色谱柱(4.6mm×150mm,5μm),以乙腈-水(40∶60)为流动相,流速1.0mL·min-1,检测波长为220nm。结果:炔雌醇及左炔诺孕酮的线性范围分别为1.554～31.08μg.mL-1(r=0.9999)和7.549～151.0μg·mL-1(r=0.9999);复方左炔诺孕酮片中炔雌醇和左炔诺孕酮平均回收率(n=3)分别为99.6%～101.8%(RSD为0.55%～1.2%)和99.5%～100.7%(RSD为0.46%～1.6%);复方左炔诺孕酮滴丸中炔雌醇平均回收率(n=3)分别为100.6%～101.1%(RSD为0.92%～1.8%)和97.9%～98.7%(RSD为1.1%～1.9%)。样品检测结果显示,复方左炔诺孕酮滴丸含量均匀度良好,但部分复方左炔诺孕酮片的含量均匀度尚不符合2005年版中国药典的相关规定。结论:建立的HPLC法具有专属性强、灵敏度高、操作简便等特点,并可考察炔雌醇和左炔诺孕酮的含量均匀度,达到严格控制药品质量的目的。
OBJECTIVE: To establish a HPLC method for the determination of ethynylestradiol and levonorgestrel in levonorgestrel and compound levonorgestrel dropping pills, and to investigate the content of levonorgestrel and drip pills Evenness. Method: The mobile phase was acetonitrile-water (40:60) with a flow rate of 1.0 mL · min-1 on a Waters Symmetry300TM C18 column (4.6 mm × 150 mm, 5 μm). The detection wavelength was 220 nm. RESULTS: The linear ranges of ethinylestradiol and levonorgestrel were 1.554 ~ 31.08μg.mL-1 (r = 0.9999) and 7.549 ~ 151.0μg · mL-1 (r = 0.9999) The mean recoveries (n = 3) of ethinylestradiol and levonorgestrel were 99.6% -101.8% (RSD 0.55% -1.2%) and 99.5% -100.7% (RSD 0.46% -1.6%), respectively. The average recoveries of ethinyl estradiol in the levonorgestrel-dropping pills were 100.6% ~ 101.1% (RSD 0.92% ~ 1.8%) and 97.9% ~ 98.7% (RSD 1.1% ~ 1.9% ). The sample test results showed that the content of compound levonorgestrel dropping pills was well-balanced, but the content uniformity of some levonorgestrel tablets still did not meet the requirements of the 2005 edition of Chinese Pharmacopoeia. Conclusion: The established HPLC method has the characteristics of high specificity, high sensitivity and easy operation. The content uniformity of ethinylestradiol and levonorgestrel can be investigated to achieve the purpose of strictly controlling the quality of medicines.