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Experimental Design Approach for Chromatographic Determination of Ketorolac Tromethamine from Bulk Drug and Tablet Formulation

Author

Listed:
  • Manwar JV
  • Patil SS
  • Bhalerao CA
  • Mandpe SR
  • Kumbhar DD

    (KYDSCT College of Pharmacy, India)

Abstract

Experimental design was successfully employed for chromatographic determination of ketorolac tromethamine from bulk drug and tablet formulation. The effect of simultaneously varying the flow rate, temperature and concentration of methanol in mobile phase water (0.05% w/v, o-phosphoric acid) on the chromatographic responses was studied using Plackett-Burman design with the help of response surface methodology (RSM). From RSM optimum regions were selected to be +1, +1 and +1 for flow rate (0.7ml/min), temperature (25 °C) and concentration of methanol in mobile phase water (0.05%w/v, o-phosphoric acid) (70%, v/v), respectively. Linearity was observed in the range of 10-50μg/ml with r2 value 0.9950. Obtained LOD and LOQ values were found to be 0.15 and 0.42μg/ml, respectively. Developed method was validated as per ICH guidelines and was successfully used for the analysis of tablet formulation.

Suggested Citation

  • Manwar JV & Patil SS & Bhalerao CA & Mandpe SR & Kumbhar DD, 2017. "Experimental Design Approach for Chromatographic Determination of Ketorolac Tromethamine from Bulk Drug and Tablet Formulation," Global Journal of Pharmacy & Pharmaceutical Sciences, Juniper Publishers Inc., vol. 3(2), pages 38-47, July.
    • Handle: RePEc:adp:jgjpps:v:3:y:2017:i:2:p:38-47
    DOI: 10.19080/GJPPS.2017.03.555609
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