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Title : Application and Validation of Two Smart Spectrophotometric and a HP-TLC Densitometric Methods for Determination of Metoclopramide Hydrochloride/ Paracetamol in Raw Material and in Pharmaceuticals
Authors : *Amira M. Hegazy, Nagiba Y. Hassan, Fadia H. Metwally, Mohammad Abdel-Kawy
Abstract : Currently the anti-emetic drug metoclopramide hydrochloride (MCP-HCl) is co-formulated with paracetamol (PCM). Three simple, economic and fast methods for determination of both drugs, simultaneously and without previous separation were developed. In first method (A), a third derivative spectrophotometric method was developed. The peaks amplitudes of third derivative spectra of MCP-HCl and PCM were measured at 334.5 and 299 nm, respectively. In second method (B), a ratio subtraction spectrophotometric method was developed. The peak amplitude of first derivative spectrum of MCP-HCl was measured at 321 nm at which PCM spectrum gives zero crossing point whereas the peak amplitude of ratio subtraction spectrum of PCM was measured at 292 nm.&nbsp; Both spectrophotomertric methods were linear within concentration range of MCP- HCl; 12-60 &micro;g/mL and PCM; 35-165 &micro;g/mL with&nbsp; high correlation coefficients.&nbsp; In third method (C), HP-TLC method was developed. The mobile phase composed of methanol, chloroform and conc. ammonia solution (10: 2: 0.15) gave typical chromatogram for MCP-HCl and PCM at Rfs 0.21 &plusmn; 0.02 &amp; 0.59 &plusmn; 0.02, respectively and the UV scanning was carried out at 270 nm. The method was linear within range of MCP- HCl; 6-18 &micro;g/mL and PCM; 5-50 &micro;g/mL giving high correlation coefficients. Complete validation process of the established methods was performed according to ICH guidelines and USP requirements and gave relative standard deviation values for all the key validation parameters less than 2.00%. <br />