摘要
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.
出处
《广东药学院学报》
CAS
2015年第2期207-209,共3页
Academic Journal of Guangdong College of Pharmacy
关键词
盐酸伐地那非
口崩片
高效液相色谱法
含量测定
vardenafil hydrochloride
orally disintegrating tablets
HPLC
content determination