枸橼酸西地那非口崩片含量均匀度的测定
Determination of content uniformity of Sildenafil citrate orally disintegrating tablets
王一帆 1樊丽娟 2肖峰 3张玲 3余仕金 3张伟4
作者信息
- 1. 昆明医科大学药学院云南省天然药物药理重点实验室,云南昆明 650500
- 2. 云南龙津康佑生物医药有限公司,云南昆明 650503;昆明龙津药业股份有限公司,云南昆明 650503
- 3. 云南龙津康佑生物医药有限公司,云南昆明 650503
- 4. 昆明龙津药业股份有限公司,云南昆明 650503
- 折叠
摘要
目的 采用UV法测定枸橼酸西地那非口崩片的含量均匀度.方法 以0.01 mol·L-1盐酸为溶剂,在292 nm处用紫外分光光度计快速测定枸橼酸西地那非口崩片的含量均匀度.结果11.14～39.89 μg·mL-1枸橼酸西地那非对照品与吸光度呈良好的线性关系;平均回收率为101.42％,RSD为0.40％;配制的样品溶液在8 h内稳定;3批枸橼酸西地那非口崩片的含量均匀度均在合格范围内,A+2.2S分别为3.54、1.98、2.70,与 HPLC法比较无明显差异.结论 所用方法操作简便快速、经济、重复性良好,可用于枸橼酸西地那非口崩片含量均匀度的测定.
Abstract
OBJECTIVE To determine the content uniformity of sildenafil citrate orally disintegrating tablets using UV spectrometry.METHODS The homogeneity of the content of sildenafil citrate orally disintegrating tablets was rapidly determined by UV spectrophotometer at the detection wavelength of 292 nm,using 0.01 mol·L-1 hydrochloric acid as solvent.RESULTS A good linear relationship was shown between the concentration of sildenafil citrate control and the absorbance in the range of 11.14-39.89 μg·mL-1.Its average recovery was 101.42％with RSD of 0.40％and the prepared sample solution was stable within 8 h.The content uniformity of the three batches of orally disintegrating tablets of sildenafil citrate was determined to be within the qualified range,with A+2.2S of 3.54,1.98,2.70,respectively.There was no significant difference compared with the HPLC method.CONCLUSION The method is simple,rapid,economical,reproducible and can be used for the determination of the uniformity of the content of sildenafil citrate orally disintegrating tablets.
关键词
枸橼酸西地那非/口崩片/含量均匀度/UV法/高效液相色普法/磷酸二酯酶5/质量控制Key words
Sildenafil citrate/Orally disintegrating tablets/Content uniformity/Ultraviolet spectrophotometry/HPLC/PDE5/Quality control引用本文复制引用
基金项目
云南省昆明市一体化科技创新专项(2022)(202202AH210003)
出版年
2024
NETL
NSTL
万方数据