Analytical Method Validation for the Detection of the Drug Sirolimus in Sugar-Coated Tablet using HPLC-DAD
DOI:
https://doi.org/10.22456/2527-2616.150632Keywords:
sirolimus, quality control, liquid chromatographyAbstract
Sirolimus (SRL) is an immunosuppressive macrolide widely used in transplant patients to prevent organ rejection. The development of an analytical method with adequate selectivity, sensitivity, and reliability is essential for its quality control and therapeutic monitoring. A validated analytical method for the quantification of SRL was developed using High-Performance Liquid Chromatography coupled with a Diode Array Detector (HPLC-DAD). The method demonstrated linearity for SRL in the concentration range of 10 to 80 μg.mL⁻¹ (r = 0.9999). Precision was confirmed with coefficients of variation below 2%, and accuracy showed recovery values close to 100%. The validated method was successfully applied to sugar-coated tablets, demonstrating its suitability for routine quality control. Therefore, the developed method can be reliably used for the quantitative analysis of Sirolimus in sugar-coated tablets.
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