Abstract

EFFECT OF SURFACTANT ON DISSOLUTION OF SIMVASTATIN TABLETS; COMPARISON WITH USP

Sakina Fatima* Shahnaz Usman and Subia Jamil

ABSTRACT

Dissolution of poor soluble drugs is carried out by using surfactant for quality control test and drug release, which closely mimics the gastrointestinal conditions. Lower concentrations of surfactant can be useful tool for dissolution in comparison with recommended value of surfactants USP. The objective of this study was to provide a comparative assessment of dissolution profile of various concentration of sodium lauryl sulphate (0.1- 0.5%) in six different brands of Simvastatin by applying dissolution profile comparison approach to check the similarity among lowest concentration (0.1%) with recommended values (0.5%). Dissolution was carried out with six units of each brand using USP apparatus-II (Paddle) at 37 ± 0.5°C in 900 ml phosphate buffer medium pH 7.0 with SLS at 50 rpm. Samples were withdrawn from the dissolution medium at 5, 10, 15, 30, 45 and 60 min interval, and analyzed by spectrophotometer at 239nm. Various statistical methods such as Model-independent methods including difference f1 and similarity factor f2, t-test and ANOVA were used for the comparison of in vitro dissolution patron among 0.1% and 0.5% SLS concentration. Results revealed that 0.1% SLS medium is sufficient for drug release of Simvastatin from tablet dosage form, five brands showed Q value = 80% in 30 minutes that is similar with recommended value of USP. The results of the study concluded that the presence of 0.1% SLS in dissolution medium improves the solubility and release profile of drug. It can also be used as a tool of quality control test for Simvastatin tablets.

Keywords: Simvastatin, SLS, drug release, Dissolution.