Abstract
A high-performance liquid Chromatographic (HPLC) method for quantification of pyridostigmine bromide and its major degradation product, 3-hydroxy-1-methylpyridinium bromide, in tablets has been developed. The method involves the use of a polymeric column with acetonitrile-water (7.8:92.2 v/v) mixture and an ion-pair reagent as mobile phase. With the injection of 4.7 μg pyridostigmine bromide the limit of quantitation of the major degradation product is 0.01 μg which corresponds to 0.21% degradation. Blister packs of tablets from a single batch number, which had been stored under different conditions in Norway and Saudi Arabia, were analysed. Degradation was determined to be 1.4–1.6%. The age of the batch was about 3 years. The method is well suited for accelerated kinetic studies and routine control of aged pyridostigmine tablets.
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