Objective of this study was development and validation of simple and precise method for quantification of Iguratimod in the rinse samples to validate cleaning procedure. Analytical methodology was optimized to get suitable precision and recovery; detection wavelength for Iguratimod was selected as 257 nm. Proposed method was validated for parameters like precision, Linearity, accuracy, limit of detection and limit of quantification. Linearity was performed for concentration range 0.1 ppm to 15 ppm, squared correlation coefficient was observed as 0.999. Recovery was observed between 90-110%. LOD and LOQ for final analytical method were 0.2ppm and 0.5 ppm respectively.
Objectives: Cleaning validation is process to assure removal of residues of active drug manufactured by using the equipments. Complete residues are removed to predetermined level for ensuring the quality of next drug to be manufactured. In current scenario, manufacturing unit do not compromised with the contamination of previously manufactured drug. These are requirements for good manufacturing practices to prevent the drug form contamination. Simultaneous object is to quantify residual Iguratimod at lower level with accurate, precise methodology by using high-performance liquid chromatographic (HPLC).
Methods: The method was developed using the isocratic solvent system, for this, an isocratic condition of mobile phase comprising buffer (pH 2.5) and methanol in a ratio of 58:42, v/v at a flow rate of 2.0 mL/minute over Water symmetry C18, 150 × 3.9 mm, 5μm) column at 40°C temperature was maintained. Use acetonitrile as diluent. By using this chromatographic system Iguratimod is successfully eluted with accuracy and precision.
Results: Analytical method validation was successfully completed for routine analysis for quantification of Iguratimod as residue. Analytical method validated for precision, linearity, accuracy, specificity, detection limit and quantification limit, etc.
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