| Abstrak/Abstract |
This study aims to develop and validate the dissolution test of isolated piperine in a solid self-nanoemulsifying drug delivery system (S-SNEDDS) using a specific and accurate reverse phase HPLC-UV method. The optimal conditions for the dissolution test were carried out at 900 mL HCl pH 1.2 and buffer phosphate pH 6.8, paddle type at a stirring speed of 50 rpm, and the test time set at 90 minutes. Separation was carried out on the C18 Phenomenex® analytical column, an isocratic mixture of methanol and water with a ratio of 75:25 v/v. The flow rate of the mobile phase of 1 mL/min with a UV detector at a wavelength of 340 nm. Validation of the analyzed methods evaluated includes specificity, linearity, linearity range, precision, accuracy, LoD, and LoQ. This validation is specific to the isolated piperine dissolution test in S-SNEDDS with a retention time of 7.69 minutes. The RP-HPLC-UV method presents linearity (r=0.9999) in the 200-1000 μg/L concentration range, Percent recovery in the range of 86.19 -94.29%, Percent intraday and interday RSD at less than 6.00 %, and LoD 9.23 μg/L and LoQ 30.77 μg/L. All validation method criteria are within the acceptable range. The developed method can be applied to the quantification analysis of S-SNEDDS isolated piperine in dissolution tests in HCl pH 1.2 and buffer phosphate pH 6.8 using USP type II (paddle type). |
