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ISSN 2063-5346
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Application of Qbd Approach for specific Analytical method development for estimation of COX 2 inhibitor- Ketorolac in tablet dosage form

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Trushali Mandhare, Dr.Uttamsing Baghel, Pooja Kashid, Pankaj Khuspe, Ganesh Phadtare, Ritesh Vyavahare
» doi: 10.53555/ecb/2022.11.11.102

Abstract

The aim of the present work was to change from the quality by testing (Qbt) prototype process which was followed in the pharmaceutical industry for quantification of chemical substances. Therefore, an effort has been taken to develop a simple, rapid and highly sensitive method for the analysis of Cox 2 Inhibitor drug Ketorolac by QbD approach using RP-HPLC method. The optimization phase was done by using QbD technique together with response surface methodology and desirability function.The Chromatographic separation was performed for Ketorolac Tromethamine drug using Phenomenex C18 150 x 4.6 mm,5 column using Acetonitrile and Phosphate buffer pH 3 (60:40% v/v), detection wavelength is 324 nm and run time is 5.9 min. Results found that Ketorolac Tromethamine shown normal co-ordinates in design space which conducted for negligible interference. The statistical data proved that the method was reliable and reproducible. The method was new, stability indicating, simple, specific, rapid, robust, accurate, and precise for analysis of NSAID- Ketorolac by RP-HPLC.

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