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  Home::Determination of cetrizine dihydrochloride and a related impurity in oral solution and tablet dosage
  Determination of cetrizine dihydrochloride and a related impurity in oral solution and tablet dosage
   

Abstract:

A new HPLC method is proposed for simultaneous determination of CZ and the synthetic impurity A in solution and solid dosage forms. This method can be an alternative to the European pharmacopoeial method where the mobile phase of pH <0.5 would cause column deterioration after few runs leading to inappropriate results. The method was found to be robust and showed good selectivity and thus it could be used as a stability indicating for the assay of CZ and related impurity A. All statistical values (percentage recoveries, R.S.D., percentage difference, confidence limits of the slope and intercept, LOD and LOQ) were within the acceptable limits [22]. Due to the presence of different interferents in solution formulations such as colors, flavors, sweetening agents (e.g. saccharin) and preservatives, the proposed method should be re-evaluated prior usage for commercial solution products containing excipients which are different than those used in this present work.                                   

Date: 11, Oct 2012 Posted By: admin
   
 
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