METHOD VALIDATION OF SIMVASTATIN IN PCL-PEG-PCL TRIBLOCK COPOLYMER MICELLES USING UV-VIS SPECTROPHOTOMETRIC FOR SOLUBILITY ENHANCEMENT ASSAY

Objective: This study aims to increase the solubility of simvastatin (SIM), a hydrophobic drug, by incorporating it into PCL-PEG-PCL triblock copolymer micelles and validating the assay method used, namely Uv-Vis spectrophotometric. Methods: The shake flask method was used to determine the increase in solubility experienced by SIM after being incorporated into the micellar system. The values ​​of maximum wavelength (λmax), linearity, LOD, LOQ, accuracy, and precision were used as parameters measured to assess the validity of the assay method used. Results: The results showed that PCL-PEG-PCL triblock copolymer micelles could increase SIM solubility by 9.7 times (89.49±5.75 µg/ml) compared to SIM without modification (9.19±0.24 µg/ml). The validation results show the λmax value of 239 nm, a linear calibration curve with an R-value of 0.9994, LOD and LOQ of 0.33 µg/ml and 1.00 µg/ml, accurate measurement with recovery at concentrations of 80%, 100%, and 120% were 102.93±1.32%, 100.78±0.40%, and 104.58±0.79% and also had good precision ​​with RSD<2%. Conclusion: The PCL-PEG-PCL triblock copolymer micelles can increase SIM solubility and the Uv-Vis spectrophotometric method has been validated successfully for the quantitative analysis of SIM in PCL-PEG-PCL triblock copolymer micelles

OPTIMIZATION OF PCL-PEG-PCL TRIBLOCK COPOLYMER MICELLES AS HYDROPHOBIC DRUG CARRIER WITH A 22 FULL FACTORIAL DESIGN

Objective: This study aims to optimize PCL-PEG-PCL (PCEC) triblock copolymer micelles as a hydrophobic drug carrier, simvastatin (SV). Methods: PCEC triblock copolymer was prepared by the ring-opening polymerization method (ROP) with different ɛCL/PEG ratio (2 and 5). SV was incorporated into the PCEC triblock copolymer micelles with a concentration of 2.5 and 10 % w/w by the solvent evaporation method (film formation). The influence of the ɛCL/PEG ratio and concentration of SV effect on the responses particle size (PS), polydispersity index (PI) and entrapment efficiency (EE) was assessed using 22 full factorial design method. The test results were analyzed using Design-Expert software to obtain the optimum formula. Result: The selection of the optimum formula is based on the desirability value, the formula with the largest desirability value is chosen as the optimum formula. The results showed the optimum formula chosen had a desirability value of 0.860 consisting of a ɛCL/PEG ratio of 5 and SV concentration of 10 % w/w, with the PS, PI dan EE value was 322.1±3.51 nm, 0.471±0.09 and 87.08±1.17 %, respectively. Conclusion: The 22 full factorial design has been proven to be used as an optimization method to determine the optimum formula of SV-loaded PCEC triblock copolymer micelles with a good result of the PS, PI and EE responses

Method Validation of Simvastatin in PCL-PEG-PCL Triblock Copolymer Micelles Using Uv-Vis Spectrophotometric for Solubility Enhancement Assay

Objective: This study aims to increase the solubility of simvastatin (SIM), a hydrophobic drug, by incorporating it into PCL-PEG-PCL triblock copolymer micelles and validating the assay method used, namely Uv-Vis spectrophotometric. Methods: The shake flask method was used to determine the increase in solubility experienced by SIM after being incorporated into the micellar system. The values of maximum wavelength (λmax), linearity, LOD, LOQ, accuracy, and precision were used as parameters measured to assess the validity of the assay method used. Results: The results showed that PCL-PEG-PCL triblock copolymer micelles could increase SIM solubility by 9.7 times (89.49±5.75 µg/ml) compared to SIM without modification (9.19±0.24 µg/ml). The validation results show the λmax value of 239 nm, a linear calibration curve with an R-value of 0.9994, LOD and LOQ of 0.33 µg/ml and 1.00 µg/ml, accurate measurement with recovery at concentrations of 80, 100, and 120 were 102.93±1.32, 100.78±0.40, and 104.58±0.79 and also had good precision with RSD<2. Conclusion: The PCL-PEG-PCL triblock copolymer micelles can increase SIM solubility and the Uv-Vis spectrophotometric method has been validated successfully for the quantitative analysis of SIM in PCL-PEG-PCL triblock copolymer micelles. © 2022 The Authors