Fast and Accurate Quantitative Determination of Prednisolone and Chlorpheniramine in Active Pharmaceutical Ingredients and Parenteral Dosage Forms

The research work entails the development of an efficient and facile method for the simultaneous quantitative analysis of Chlorpheniramine (CPM) and Prednisolone (Pred) with reasonable accuracy and precision both in active pharmaceutical ingredient (API) and its parenteral dosage form. C18 (5µm x 150 mm 4.6 mm) HPLC column was used using 50:50 v/v acetonitrile: buffer 0.008M sodium dihydrogen phosphate (NaH2PO4) as mobile phase. The run time for the analysis was 10 min. The retention times of CPM and Pred were 1 and 4 minutes. The developed method showed linearity, intermediate precision and accuracy within the defined limits set according to international standards. Verification of this method was done on parenteral dosage form of both the drugs. Linearity with R2 values of 0.991607 for CPM and 0.990061 for PRED was obtained. Limit of detection and limit of quantification for PRED were calculated 0.033 mg. mL-1 and 0.11 mg. mL-1 while for CPM, 0.08 mg. mL-1 and 0.27 mg. mL-1 were obtained. Accuracy parameters outcomes for PRED, were within range of 98.16576% to 98.46571% and the values for CPM were 98.10% to 99.57% Validation results of the developed method are accurate and within system suitability parameters provided by ICH and pharmacopeias.