Abstract
A validated, sensitive, and highly selective stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been adopted for the quantitative determination of pyridostigmine bromide in the presence of its alkaline-induced degradation product and in pharmaceutical formulations. 3-hydroxy-N-methyl pyridinium bromide (3-OH NMP) is the metabolite, impurity, and alkaline-induced degradation product of pyridostigmine bromide (PB). Pyridostigmine bromide and its alkaline-induced degradation product were separated on silica gel HPTLC F-254 plates using methanol-ethyl acetate-triethyl amine-glacial acetic acid (9:1:0.5:0.05 by volume) as the developing system followed by scanning of the separated bands at 270 nm over a concentration range of 2-10 mu g band(-1) with mean percentage recoveries of 99.84% (SD 1.384). The proposed method was successfully applied to the analysis of pyridostigmine bromide both in bulk powder and in pharmaceutical formulation without interference from other dosage form additives. The results obtained by the proposed method were statistically compared with those obtained by the reported HPLC method with no significant difference regarding both accuracy and precision, indicating the ability of the proposed method to be reliable and suitable for routine analysis of a drug product.