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Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF KETOROLAC TROMETHAMINE IN BULK DRUG

Rupinder Kaur*, Sukhdev Singh, Aaliya Hassan, Sunny Jalhan and Upendra K Jain

ABSTRACT

The aim of the study was to develop and validate robust, accurate and precise UV spectrophotometric method for determination of Ketorolac Tromethamine. The developed method was validated as per International Conference on Harmonization (ICH) guidelines. The spectrophotometric detection was carried out at an absorption maximum of 322 nm using water as solvent. The method was validated for specificity, linearity, accuracy, precision, robustness and ruggedness. The detector response for the Ketorolac Tromethamine was linear over the selected concentration range 2 to 14 μg/ml with a correlation coefficient of 0.998. The accuracy was between 98 to 101%. The LOD and LOQ are 0.031 and 0.00967 μg/ml respectively.

Keywords: Ketorolac Tromethamine, UV spectrophotometry, Validation.


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