Effect of different excipients on the stability of simvastatin tablets
HE Zhong-gui · Chinese Journal of Pharmaceutics · 2009
Objective To select suitable excipients for simvastatin tablets.Methods Various kinds of simvastatin tablets were prepared with different excipients, and the stability of the simvastatin in tablets was investigated under different conditions.The drug content and related substances in the samples were determined by RP-HPLC method and compared with those of 0 d samples.Results Citric acid increased the related substance of simvastatin in tablets under high humidity;simvastain tablets using magnesium stearate or stearic acid as lubricants were unstable under high temperature, and the content of simvastatin decreased significantly and the amount of the related substances increased;the addition of butylated hydroxyanisole as an antioxidant also increased the amount of the related substance of simvastatin in tablets under high humidity and high temperature.In contrast, tablets using glyceryl behenate as a lubricant could maintain the stability of simvastatin.Conclusions Citric acid, magnesium stearate, stearic acid and butylated hydroxyanisole are unsuitable to be used as excipients for simvastatin tablets with the exception of glyceryl behenate.