Abstract
DEVELOPMENT AND VALIDATION OF A NEW UV-SPECTROPHOTOMETRIC METHOD FOR THE ANALYSIS OF REBAMIPIDE IN ACTIVE PHARMACEUTICAL INGREDIENT AND PHARMACEUTICAL DOSAGE FORM
Duddagi Suchitra*, Akulas Shushma, Sukanya Mandala, R. Srujana
ABSTRACT
A Novel, rapid, sensitive, simple and cost-effective UV-Spectrophotometric method was developed for the estimation of Rebamipide in active pharmaceutical ingredient. The relative absorbance of Rebamipide was measured in methanol at new wave length (λmax 228). This method is simpler and more economical than few reported methods as it utilized methanol, offering a relatively greener, more cost-effective and improved method robustness. The developed method exhibited linearity in the range of 1-10 µg/ml. The correlation coefficient of Rebamipide was found to be 0.999 which confirmed the strong linear relationship between absorbance and concentration confirming the methods suitability for quantitative analysis. It is validated for various parameters as per ICH and USP specifications. The detection and quantification limit were found to be 1.1µg/ml and 3.6 µg/ml respectively. The result demonstrates that the developed procedure is accurate, precise and reproducible (Relative standard deviation <2.0%). The Proposed method is applicable for the routine Quality control analysis and for estimation of the retest period of Rebamipide in Bulk form.
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