DOI: 10.36347/sajp.2023.v12i02.001

Pages: 21-31

The analytical method was developed to evaluate the effectiveness of the procedure to clean the remains of the active pharmaceutical ingredients (APIs) from the equipment surface after manufacture of the final product. For this validation, High Performance Liquid Chromatographic (HPLC) method has been chosen. The HPLC chromatographic separations were achieved using C18 (150×4.6 mm), 5µm, column, employing buffer solution and organic solvent in the ratio of 70:30 (v:v) as mobile phase with the flow rate 1.0 ml/min. The column temperature was maintained at 25 °C and a detector wavelength of 225 nm was employed. Method validation study was conducted on eight separate surfaces. In this paper, stainless steel surface, one of the eight surfaces, was chosen since it is the most widely used surface during the manufacture of the finished product including immunomodulating agent. Validation study was studied between the linearity levels of 2.7% (LOQ% level) and 300%. The method was successfully validated by establishing specificity, linearity, precision (system precision, repeatability, and intermediate precision), accuracy, robustness, solution stability and limit of detection (LOD) & limit of quantification (LOQ) for immunomodulating agent raw material.