HPLC法测定盐酸伐地那非口崩片中盐酸伐地那非的含量

Determination of vardenafil hydrochloride orally disintegrating tablets by HPLC

目的建立HPLC法测定盐酸伐地那非口崩片中盐酸伐地那非质量分数的方法。方法色谱柱为Diamonsil-C18色谱柱（250 mm×4.6 mm,5μm）,以乙腈-0.068%（体积分数）KH2PO4[体积比55∶45,25%（体积分数）Na OH调p H值为7.5]为流动相,流速为1.0 m L/min,检测波长为214 nm,柱温为30℃,进样量为10μL。结果盐酸伐地那非进样量在30.02~300.30μg/m L范围内线性关系良好（r=0.999 7）,平均回收率为101.67%,RSD=1.6%。结论本方法准确、可靠、专属性强,能满足制剂质量标准的要求,可用于盐酸伐地那非口崩片的质量控制。

Objective To establish a determination method for vardenafil hydrochloride orally disintegrating tablets. Methods HPLC was performed on Diamonsil-C18（250 mmx4.6 ram,5 txm） with a mobile phase consisted of acetonitrile-0.068% （φ） potassium dihydrogen phosphate [ 55：45, pH adjusted to 7.5 with 25% （φ） NaOH] ,and the flow rate was 1.0 mL/min. The UV detection wavelength was 214 nm and the column temperature was 30 ℃. The sample volume was 10 μL. Results The linear range of vardenafil hydrochloride was 30.02-300.30 μg/mL （r = 0.999 7） with an average recovery of 101.67%, RSD = 1.6%. Conclusion The method was accurate, reliable and specific, which could meet the requirements of quality standards and be used for quality control of the vardenafil hydrochloride orally disintegrating tablets.