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Title Establishment and validation of Two Smart UV-Spectrophotometric and a Novel Spectrodensitometric Methods for Simultaneous Determination of Metoclopramide Hydrochloride/ Pyridoxine Binary Mixture in Raw Material and in Syrup
Authors *Amira M. Hegazy, Nagiba Y. Hassan, Fadia H. Metwally, Mohammad Abdel-Kawy
Description Currently the anti-emetic drug metoclopramide hydrochloride (MCP-HCl) is co-formulated with pyridoxine (VB6). Three simple, economic and fast spectroscopic methods for determination of both drugs, simultaneously and without previous separation were developed. The first method is a ratio derivative spectrophotometry. The peaks amplitudes of first derivative spectra of MCP-HCl and VB6 were measured at 318.5 nm and 327.5 nm, respectively. The second one is an isosbestic point spectrophotometry. The peaks amplitudes of MCP-HCl and VB6 spectra were measured at 321.5 and 299.5 nm, respectively. The third method is spectrodensitomerty. The mobile phase was composed of benzene, methanol, glacial acetic acid, and acetone (10: 8: 0.5: 0.5; by volume). It gave typical chromatogram for MCP-HCl and VB6 at Rfs 0.2 &plusmn; 0.02 &amp; 0.51 &plusmn; 0.01, respectively and the UV scanning was carried out at 245 nm. Complete validation processes of the established methods were performed according to ICH guidelines and USP requirements.&nbsp; All methods were linear within wide concentrations ranges with high correlation coefficients.&nbsp; The proposed methods showed high accuracy, precision and selectivity results. Relative standard deviation values for all the key parameters were less than 2.00%. <br />