DOI: 10.21276/sajp.2018.7.12.6

Pages: 493-502

The analytical method has been developed to evaluate the efficacy of the cleaning procedure of all the equipment involved in the production of final active ingredients. The choice of the methodology is based upon the production method and on the intrinsic properties of the products. For this validation HPLC method has been chosen. The HPLC chromatographic separations were achieved on (100×4.6 mm), 3.5µm, column make: Phenomenex, employing acetonitrile and 0.4% orthophosphoric acid aqueous solution in the ratio of 35:65 as mobile phase with flow rate 1.0 mL/min was chosen. The column temperature was maintained at 25oC and a detector wavelength of 254 nm was employed. The method was successfully validated by establishing System Suitability, Specificity, Linearity, Accuracy, and limit of detection and Limit of quantification for Pramipexol Dihydrochloride Monohydrate.