盐酸伐地那非口腔崩解片有关物质的研究

周雨华, 汤丹, 周金花, 曾卓智, 高曙光

中国药学杂志 ›› 2016, Vol. 51 ›› Issue (20) : 1790-1794.

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中国药学杂志 ›› 2016, Vol. 51 ›› Issue (20) : 1790-1794. DOI: 10.11669/cpj.2016.20.015
论著

盐酸伐地那非口腔崩解片有关物质的研究

  • 周雨华, 汤丹*, 周金花, 曾卓智, 高曙光
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Quantitative Analysis of Impurities in Vardenafil Hydrochloride Orally Disintegrating Tablets

  • ZHOU Yu-hua, TANG Dan*, ZHOU Jin-hua, ZENG Zhuo-zhi, GAO Shu-guang
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摘要

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 C18-WP柱(4.6 mm×250 mm,5 μm);以醋酸盐溶液(取醋酸铵0.8 g,加水900 mL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 mL使溶解)-乙腈(10∶90)为流动相B,1.0 mL·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。

Abstract

OBJECTIVE To establish a method for quantitative analysis of the impurities in vardenafil hydrochloride orally disintegrating tablets.METHODS Gradient elution at the flow rate of 1.0 mL·min-1 was used for the determination of known impurities A-E and the unknown impurities simultaneously. The separation was performed on Athena C18-WP column (4.6 mm×250 mm,5 μm) with acetate solution containing 0.8 g ammonium acetate in 900 mL of water-acetonitrile (90∶10) as mobile phase A and acetate solution containing 0.8 g ammonium acetate in 100 mL of water-acetonitrile (10∶90) as mobile phase B. The UV detection was carried out at 245 nm, and the column temperature was maintained at 40 ℃. RESULTS After being treated with oxidation, heat, and light, vardenafil underwent more or less degradation. The degradation products were effectively separated and detected using this method.Meanwhile, the method showed good specificity, linearity, and ruggedness. CONCLUSION The method is selective, sensitive, and accurate, and it is suitable for the quality control of vardenafil hydrochloride orally disintegrating tablets.

关键词

盐酸伐地那非 / 有关物质 / 高效液相色谱法

Key words

vardenafil hydrochloride relation / impurity / HPLC

引用本文

导出引用
周雨华, 汤丹, 周金花, 曾卓智, 高曙光. 盐酸伐地那非口腔崩解片有关物质的研究[J]. 中国药学杂志, 2016, 51(20): 1790-1794 https://doi.org/10.11669/cpj.2016.20.015
ZHOU Yu-hua, TANG Dan, ZHOU Jin-hua, ZENG Zhuo-zhi, GAO Shu-guang. Quantitative Analysis of Impurities in Vardenafil Hydrochloride Orally Disintegrating Tablets[J]. Chinese Pharmaceutical Journal, 2016, 51(20): 1790-1794 https://doi.org/10.11669/cpj.2016.20.015
中图分类号: R917   

参考文献

SANFORD M. Vardenafil orodispersible tablet. Drugs, 2012, 72(1):87-98.
HEINIG R, WEIMANN B, DIETRICH H, et al. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil. Clin Drug Invest, 2011, 31(1):27-41.
EP(8.2) VolⅡ. 2014:4111-4112.
WANG B, LI H Q, LIAN X Y, et al. RP-HPLC assay method for related substances of ambrisentan tablets . Chin Pharm J(中国药学杂志), 2015, 50(6):541-544.

基金

广州市珠江科技新星专项资助项目(201506010062)
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