| Popis: |
Background: Poor solubility of teriflunomide leading to poor bioavailability in disease conditions was a challenge that could be overcome by currently formulated SLNs. Hence, the development of a sensitive, accurate method for solid-lipid nanoparticles carrying teriflunomide is significantly required to analyze and quantify the drug in formulation and drug release samples. The main aim of this study is to develop a simple, linear, precise, accurate, and sensitive RP-HPLC with a UV detection method that has been developed and validated for the determination of teriflunomide in SLNs and other marketed formulations. Application of the same to determine %drug loading, %drug entrapment efficiency (DEE), and quantification of drug release studies. Materials and Methods: Method optimization was carried out by using the various parameters (different Mobile phases with varying pH and Columns). The chromatographic separation was carried out by using Shim-pack GIST C18 (4.6 x 100mm, 5 µm) column, with a 70:30 v/v ratio, potassium dihydrogen phosphate, and acetonitrile make up the mobile phase, column temperature of 50˚C with 10min runtime and injection volume 10µL with flow rate 1.5mL/min. The effluent was detected by using a UV detector at 250nm. Results and Discussion: Developed analytical method has a linearity range between 1-64µg/ml and a correlation coefficient (R2) value of 0.996. The limit of detection (LOD) of 0.98 µg/ml and the Limit of quantification (LOQ) of 1.05µg/ml with a % recovery of 98.2% and drug entrapment efficiency (DEE) was found to be 88.95. Conclusion: In this study, a simple, accurate, sensitive, and repeatable RP-HPLC method was developed for the quantification of teriflunomide in SLNs.The developed method was validated according to ICH Q2 (R1) guidelines and the Developed method was found to be accurate, linear, robust, and precise Developed analytical method was applied for determining drug release, %drug loading, and drug entrapment efficiency (DEE). |
