Evaluation of Metrological Characteristics for Quantitative Spectrophotometric Determination of Prednisolone by an Optical Absorbance Method

摘要

Optical absorption spectroscopy (OAS) is used in Ukraine mainly for laboratory quality control of medicines. This technique is introduced into regulatory analytical documentation only when the permissible limit of drug substance in the medicine is at least +/- 10%. Results from validation tests in two different laboratories of three batches of prednisolone substance were assessed in order to determine the correctness of using OAS for its pharmacopoeial analysis. The practical uncertainty of the OAS spectrophotometric analytical technique for each sample of prednisolone substance analyzed individually in the two laboratories was less than the regulated critical tolerance of +/- 3% according to the State Pharmacopoeia of Ukraine. The results allowed the OAS method to be recommended for quality control of prednisolone substance provided the equipment is qualified and the correctness of the results is controlled.