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Abstract
Different methods for the determination of some gastrointestinal drugs including Roxatidine acetate, Tiemonium methylsulphate and Pinaverium bromide were studied. For Roxatidine acetate, stability-indicating TLC-Densitometric, HPLC, ion selective electrode and spectrophotometric D1 methods in the presence of its hydrolytic degradation products have been developed besides establish the degradation pathway by LC-MS. For Tiemonium methylsulphate, stability-indicating TLC-densitometric, HPLC, and spectrophotometric isoabsorptive point, ratio subtraction, D1 and DD1 methods in the presence of its degradation products have been developed besides establish the degradation pathway by LC-MS. For Pinaverium bromide, stability-indicating TLC-densitometric, HPLC and ion selective electrode in the presence of its acid degradation product have been developed besides establish the degradation pathway by LC-MS. All the proposed methods were used for the determination of the cited drugs in bulk powder, pharmaceutical formulations, in presence of their degradation products. The validation was assessed according to ICH guidelines. The obtained results were statistically compared to the manufacturer{u2019}s ones with no significant difference between them