Pramulani Mulya Lestari - Laboratory of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Indonesia, Depok, West Java, Indonesia
Melva Louisa - Department of Pharmacology and Therapeutics, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
Yahdiana Harahap - Bioavailability/Bioequivalence Laboratory, Faculty of Pharmacy, Universitas Indonesia, Depok, Indonesia
Silvia Surini - Laboratory of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Indonesia, Depok, West Java, Indonesia

Atorvastatin calcium is an antihyperlipidemic agent with low bioavailability due to the first-pass metabolism after oral administration. To overcome the limitation, an alternative method for delivering drug molecules to the systemic circulation is needed, such as transethosomes produced for transdermal delivery. Therefore, this study aimed to produce atorvastatin calcium transethosomes with characteristics suitable for transdermal delivery using validated analytical method. Transethosomes formulations were prepared with different concentrations of soy lecithin and ethanol. All formulations were evaluated for particle size, zeta potential, polydispersity index (PDI), drug content, and deformability index. Validation of the analytical method of atorvastatin calcium was carried out using system suitability, selectivity, linearity, limit of detection (LOD), limit of quantification (LOQ), precision, accuracy, and robustness. The result showed that transethosomes had a small particle size of ۱۲۳.۹۰ nm-۱۶۵.۱۰ nm, high zeta potential values, acceptable PDI, the highest atorvastatin calcium content, and good deformability index. In addition, the system suitability test results were acceptable and there was no interference in the atorvastatin calcium area. Linearity showed r =۰.۹۹۹۹ with LOD and LOQ values of ۰.۳۸۸ µg/mL and ۱.۱۷۶ µg/mL, respectively. The % RSD in the precision was < ۲ and the recovery in the accuracy was ۹۸.۷۶%-۱۰۱.۰۴%. The method proved to be robust with respect to mobile phase pH changes. Based on the results, atorvastatin calcium-loaded transethosomes were suitable for transdermal delivery and could be effectively produced with a ۳% soy lecithin and ۳۰% ethanol concentration. The analytical method for determining drug content of atorvastatin calcium-loaded transethosomes could be effectively applied.

Atorvastatin calcium, Transethosomes, Transdermal drug delivery, Validation