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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