Real-time dissolution of simvastatin tablets manufactured by 3 factories / 中国现代医生

ABSTRACT

Objective To compare the real-time dissolutions of 3 kinds of Simvastatin tablets used in our hospital, and provide reference information for clinical applications. Methods The dissolution rate of simvastatin tablets was deter-mined by the Chinese Pharmacopoeia 2010, and the HPLC method was used to determine the simvastatin content at the wavelength of 238 nm and the Weibull’s equation was adopted to fit the dissolution curves. The shape parameters (m) were performed statistical analysis; Using the similarity f2 as the index, compared the dissolution curve between tablets and the preparation. Results The dissolution of simvastatin tablets manufactured by the 3 manufaccturer was no less than 90% in 30 min, which comply with the national specifications. Compared with the dissolution curve of 6 tablets from the same batch, the homogenicity of samples from A was better, with poor homogenicity of tablets from B or C. There’s significant difference in the shape parameter m of tablets from B and C (P< 0.05), and there’s no significant difference in m of tablets from C and A(P>0.05). Conclusion The in vitro dissolution of the simvastatin tablets are de-termined with single point test procedures. The dissolution of the tablets from 3 manufactures comply with national specifications. However, there’s significant difference in real time dissolution of national tablets. It’s necessary to im-prove the quality of national tablets. Cautions should be taken while use in clinical practices.