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An Investigation of Atorvastatin Calcium Loaded Transethosomes for Transdermal Delivery and Validation of HPLC Methods
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 123.90 nm-165.10 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 =0.9999 with LOD and LOQ values of 0.388 µg/mL and 1.176 µg/mL, respectively. The % RSD in the precision was < 2 and the recovery in the accuracy was 98.76%-101.04%. 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 3% soy lecithin and 30% ethanol concentration. The analytical method for determining drug content of atorvastatin calcium-loaded transethosomes could be effectively applied.
Journal of Medicinal and Chemical Sciences
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