DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF DORIPENAM IN BULK AND PHARMACEUTICAL DOSAGE FORMS
P. Pravalika Reddy*, Dr. G. Tulja Rani and T. Devi
In the present work a simple, accurate and cost effective UV Spectrophotometric method has been developed for determination of Doripenem in bulk and pharmaceutical formulations. The optimum conditions for the analysis of drug are established and Doripenem is found to exhibit maximum absorption at 298 nm with water as solvent. The present method is validated as per guidelines of the International Conference on Hormonization (ICH) including parameters like linearity, accuracy, precision, limit of detection and limit of quantification. Drug obeyed Beer's law in concentration range of 10-50μg/ml and the regression equation is found to be Y=0.0239X+0.0105 with correlation coefficient 0.999. From the results it is observed that good correlation exist between drug concentration and absorbance. The percent recovery of Doripenem is found to be 98.3-99.57. The precision is evaluated and relative standard deviation (RSD) is less than 2%, LOD & LOQ are 0.133 & 0.40 respectively. The method is applied to marketed formulation (Doricrit) and Doripenem content is found to be 99.2 with respect to labeled claim. The results suggest that this method can be employed for routine analysis of Doripenem in bulk and commercial pharmaceutical formulations.
Keywords: Doripenem, Spectrophotometric method and Validation.
[Full Text Article]