Sholichah Rohmani, Adi Yugatama, Bambang Bagus Suryadi, Felicitas Lady F., Ahmad Ainurofiq, Fea Prihapsara

Abstract

Atorvastatin is a statin drug used as the first-line treatment for hyperlipidemia. This patent was used up in 2011. Currently, in Indonesia, there are circulating preparations of atorvastatin tablet innovators, several branded names, and generics. This study was conducted to determine the quality of atorvastatin preparations circulating in Indonesia through physical quality tests in the form of performance tests, weight uniformity, hardness, friability, disintegration time, determination of levels using a UV-Vis spectrophotometer, and dissolution test. Dissolution test using aquades medium and buffer solutions with pH 1.2, 4,5, and 6.8 with a volume of 900 ml, stirring speed of 100 rpm, temperature of 37°C ± 0.5, and testing time for 45 minutes. Tests were carried out on three samples, namely the innovator, branded, and generic atorvastatin tablet samples. All three tablet samples met all physical criteria, including uniformity in weight, hardness, friability, and disintegration time. The results of the determination of atorvastatin levels for innovator, branded, and generic tablets met the content requirements of not less than 90.0%, and no more than 110.0% of the amount stated on the label. The dissolved profile of branded atorvastatin tablets is similar to the innovator, while the profile of generic atorvastatin tablets is not similar to innovator tablets‎.