DEVELOPMENT AND VALIDATION OF A ULTRA PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR ASSAY OF CETIRIZINE DIHYDROCHLORIDE

摘要

Objective: The main objective of current study is to develop and validate UPLC method, simple, precise, accurate and specific chromatogr aphic method for the determination of cetirizine dihydrochloride in tablets. Methods: An ultra performance liquid chromatography instrument and silica, 33 x 4.6 mm, 3 μ were used for determination of cetirizine dihydrochloride. The flow rate of 1.0 mL/min was set with isocratic, the temperature of column compartment maintained at 25°C and Ultra violet detection done at 230nm wavelength. The injection volume was 5 μL. The cetirizine dihydrochloride peaks eluted at 1.202 minute and run time was set as about 2 minutes. Results: The correlation coefficient (≥ 0.999) shows the linearity of response against concentration over the range of 10 to 300%. The observed result shows that the method was rapid, precise, accurate and simple. The method was validated as per ICH guidelines. Conclusion: The developed and validated an ultra performance liquid chromatographic method was suitable for determination of cetirizine dihydrochloride in pharmaceutical formulations which is more useful with respect to regular laboratory analysis. This method can be conveniently used in a quality control laboratory for ro utine analysis of cetirizine dihydrochloride