抽象的

Validated chromatographicmethods for determination of paracetamol, pseudoephedrin and cetirizin in pharmaceutical formulation

Maha A.Hegazy, Fatma E.khattab, Basma M.Abdelhameed

Two specific, sensitive and precise stability indicating chromatographic methods had been developed, optimized and validated for determination of Paracetamol (PAR), Pseudoephedrin (PS) and Cetirizin (CET) in their laboratory prepared mixtures and pharmaceutical formulatios. The first method was based on thin layer chromatographic densitometry (TLC). The optimum separation was achieved using silica gel 60 F254Aluminum TLC plates and ethyl acetate: methanol: ammonia (75: 20: 5 by volume) as a developing system. Good correlations were obtained in the ranges of (1- 12mgml-1) for PAR and PS and (3-15mgml-1) for CET. The second method was based on high performance liquid chromatography with ultraviolet detection (HPLC-UV), at which the proposed components were separated on a reversed phase C18 column using phosphate buffer(pH 3.6): acetonitrile (1: 1.2 by volume) as the mobile phase, maintaining constant flow rate of 1mLmin-1 and detection at 210 nm. Linear regressions were obtained in the ranges of 1.0-60, 1.0-50 and 0.1-60 µgmL- 1 for PAR, PS and CET, respectively. Different parameters affecting the suggested methods had been optimized in order to obtain maximum separation of the cited components. System suitability parameters of the two developed methods were also tested. The suggested methods were successfully applied for determination of PAR, PS and CET in their commercial capsules. Both methods were validated in compliance with the ICH guidelines with satisfactory results. Also they were statistically compared to each other and to the reportedmethod, no significant difference was found, providing their accuracy and precision.