|
|
|
| Dissolution determination for vitamin B2 in compound vitamin B tablets and its evaluation |
| YE Aiqin. #br# |
| Department of Pharmacy, Zhejiang Wenzhou Chinese Medicine Hospital, Wenzhou 325000, China |
|
| Cite this article: |
|
YE Aiqin.. Dissolution determination for vitamin B2 in compound vitamin B tablets and its evaluation[J]. JOURNAL OF WEZHOU MEDICAL UNIVERSITY, 2020, 50(5): 406-410.
|
|
|
|
Abstract Objective: To establish a method to determine the dissolution of vitamin B2 in compound vitamin B tablets and evaluate the dissolution curves of different samples. Methods: The HPLC was used, and the separation was performed on a CAPCell PAK C18 (4.6 mm×250 mm, 5 μm) column with the mobile phase consisting of the solution containing 2 mmol/L sodium heptane sulfonate and 50 mmol/L ammonium dihydrogen phosphate-acetonitrile (85:15) at a flow rate of 1.0 mL/min. The column temperature was 35 ℃. The detection wavelength was 267 nm. The paddle method was used for the dissolution test of vitamin B2 with 600 mL water as the medium and the rotation rate was set at 75 r/min. Results: Under the chromatographic condition in this study, vitamin B2 (Riboflavin) revealed good linearity within the range of 0.126-5.023 μg/mL (r=0.9999). The average recovery was 103.7%, 100.0% and 99.4% respectively at low, intermediate and high concentration, with the RSD being 0.7%, 1.3%, 0.3%, respectively. The dissolution method was suitable for showing differences in dissolutions among products of different manufacturers. Conclusion: The established HPLC method is simple, which shows good specificity, precision and accuracy. The dissolution method can reflect differences among products of different manufacturers. Some manufacturers should improve the production process, strengthen the dissolution of products to improve the effectiveness of drugs.
|
|
Received: 12 November 2019
|
| |
|
|
|
[1] 中华人民共和国卫生部药典委员会. 中华人民共和国卫 生部药品标准——化学药品及制剂(第一册)[M]. 北京: 人 民卫生出版社, 1989.
[2] 葛雪松, 庄航, 孙桐, 等. 不同厂家符合维生素B片中维生 素B2的溶出度考察[J]. 中国医药指南, 2012, 10(27): 42-43.
[3] 国家药典委员会. 国家药品标准工作手册: 国家药品标准 技术规范[M]. 4版. 北京: 中国医药科技出版社, 2013: 147148.
[4] 国家药典委员会. 中华人民共和国药典[M]. 2015年版. 北 京: 中国医药科技出版社, 2015: 1233.
[5] 薛晶, 李娅萍, 南楠, 等. 维生素B2片的一致性评价方法研 究[J]. 中国现代应用药学, 2018, 35(8): 123-125. |
|
|
|
