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目的建立新药盐酸伐地那非口腔崩解片有关物质的分析方法。方法采用梯度洗脱高效液相色谱法同时测定制剂中5个已知杂质A~E及未知杂质,色谱柱为Athena C_(18)-WP柱(4.6 mm×250 mm,5μm);以醋酸盐溶液(取醋酸铵0.8 g,加水900 m L使溶解)-乙腈(90∶10)为流动相A,醋酸盐溶液(取醋酸铵0.8 g,加水100 m L使溶解)-乙腈(10∶90)为流动相B,1.0 m L·min-1的流速,梯度洗脱;检测波长245 nm,柱温40℃。结果在氧化、高温、光照破坏条件下,伐地那非产生不同程度的降解,采用建立的方法可有效检出降解产物;伐地那非与各杂质分离良好,经验证该方法的专属性、线性、耐用性等良好。结论该法专属性强、灵敏度高、准确性好,可用于盐酸伐地那非口腔崩解片的质量控制。
OBJECTIVE To establish a method for the analysis of related substances of the new drug vardenafil hydrochloride orally disintegrating tablets. Methods Five known impurities A ~ E and unknown impurities in the preparation were determined by gradient elution high performance liquid chromatography (HPLC). Athena C 18 column (4.6 mm × 250 mm, 5 μm) Salt solution (take ammonium acetate 0.8 g, add water 900 m L to dissolve) - acetonitrile (90:10) as mobile phase A, acetate solution (take ammonium acetate 0.8 g, add water 100 m L to dissolve) : 90) as the mobile phase B, the flow rate of 1.0 m L · min-1, gradient elution; detection wavelength 245 nm, column temperature 40 ℃. Results Vardenafil was degraded to varying degrees under the conditions of oxidation, high temperature and light. The degradation products were detected by established method. Vardenafil was separated from the impurities well. The specificity, Linear, durable and so good. Conclusion The method is highly specific, sensitive and accurate. It can be used for quality control of vardenafil hydrochloride orally disintegrating tablets.