Development and Validation of Stability Indicating HPTLC Method for Determination of Pyridostigmine bromide in the Presence of its Alkaline-Induced Degradation Product

Research Abstract

Validated, sensitive and highly selective stability indicating HPTLC- method is adopted for quantitative determination of pyridostigmine bromide in the presence of its alkaline-induced degradation product and in pharmaceutical formulations. The alkaline- induced degradation product, metabolite, and impurity of Pyridostigmine Bromide (PB) is 3-hydroxy-N-methyl pyridinium bromide (3-OH NMP). Pyridostigmine Bromide and its alkaline-induced degradation product are separated on silica gel HPTLC F254 plates using methanol: ethylacetate: triethyl amine : glacial acetic acid (9: 1: 0.5: 0.05 by volume) as a developing system followed by scanning of the separated bands at 270 nm over a concentration range of 2-10 μg/band with mean percentage recoveries 99.84% (S.D. 1.384). The proposed method was successfully applied to the analysis of pyridostigmine bromide either in bulk powder or 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 drug product.

Research Keywords

Pyridostigmine bromide; HPTLC; stability indicating analysis; degradation; validation; accuracy