Abstract

ASSAY METHOD FOR -DEXLANSOPRAZOLE BY ULTRAVIOLET SPECTROMETER

Likitha V., Mamatha B., Maviya Iqbal, NJR. Hepsebah*, Praveen, Pravalika B. and Santhoshini T.

ABSTRACT

Background: Context- Dexlansaprazole is a drug that has poor solubility in the aqueous solvents. Thus, methods that are developed have used organic solvents and determined the assay of the drug. There is a scope to develop a method using polar solvents, as the drug shows solubility in basic polar solvents. Purpose of study:- The main aim of the article is to develop a simple assay method for Dexlansoprazole capsules by UV spectroscopy and to validate as per ICH guidelines. Method: Dexlansoprazole is an organic compound used in the treatment of acidity, this drug has poor solubility in aqueous solvents. Thus, a method is developed where the solubility of drug is achieved in aqueous solvent that is 3 N NaOH and the assay was determined which is found to be 108%. Results: In the optimised method for assay, working concentration of standard and sample is 10μg/ml and a detection wavelength of 224 nm. Main Findings:- The developed method represented- Dexlansoprazole exhibiting linearity in the range 1-10μg/ml. System precision and intra-day precision resulted in relative standard deviation of 0.22% and 0.820% respectively. Inter day precision was found to be - %RSD 0.29%. Percentage Mean recovery was found to be in the range of 90-110 % by absolute method during accuracy studies. Conclusion: A Brief Summary -Hence it can be concluded that aqueous solvents like NaOH can be used for performing assay of Dexlansoprazole, because the drug is completely soluble and shows good percentage of assay. Potential Implications-To conclude a simple cost effective and accurate method is developed by using uv- spectrometer and is validated as per ICH guidelines. The developed method can be used in routine analysis in myriad pharmaceutical industries and can save time and money of various scientists.

Keywords: dexalansopraole, UV, Validation, ICH.