DEVELOPMENT OF SPECTROPHOTOMETRIC AND FLUOROMETRIC METHODS FOR ESTIMATION OF DARUNAVIR USING QBD APPROACH

  • R. D. Godambe Tatyasaheb Kore College of Pharmacy Warananagar, Dist: Kolhapur (MS) India
  • J. I. Disouza Tatyasaheb Kore College of Pharmacy Warananagar, Dist: Kolhapur (MS) India
  • C. M. Jamkhandi Tatyasaheb Kore College of Pharmacy Warananagar, Dist: Kolhapur (MS) India
  • P. S. Kumbhar Tatyasaheb Kore College of Pharmacy Warananagar, Dist: Kolhapur (MS) India

Abstract

Objective: The main objective of the present study is to develop newer simple, precise spectrophotometric and fluorometric methods of estimation for Darunavir using coupling agent O-pthaladehyde.

Methods: The experimental work was designed for both spectroscopic and fluorometric method development and validation. The method is based on formation complex of Darunavir with O-pthaladehyde. QbD approach was applied by varying different parameters. These parameters were designed into Ishikawa diagram.

Results: The complex Darunavir-Phthalaldehyde in methanol with 0.1 N HCl showed linearity for both spectrophotometric and fluorometric methods. The calibration curve by spectrophotometry is linear in concentration range of 2-22 µg/ml with regression coefficient (R2) = 0.998 at 355 nm and for fluorometry it is linear in concentration range of 0.5-5.0 ng/ml with regression coefficient (R2) = 0.999. This method was found to be rugged and robust in different testing criteria with % RSD less than 2. The limit of detection and limit of quantification was found to be 0.2 μg/ml and 0.8 μg/ml for a spectrophotometric method and 0.12 μg/ml and 0.43 μg/ml for fluorometric method respectively.

Conclusion: Both methods were found to be precise with % RSD of less than 2. The % recovery of the spectrophotometric and fluorometric methods was found to be 101.04 %, 98.15 % respectively. In this way, the results of all validation parameter were within the limits as per International Conference on Harmonization guideline.

 

Keywords: Spectrophotometry, Fluorometry, Darunavir, Condensation reaction

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Godambe, R. D., J. I. Disouza, C. M. Jamkhandi, and P. S. Kumbhar. “DEVELOPMENT OF SPECTROPHOTOMETRIC AND FLUOROMETRIC METHODS FOR ESTIMATION OF DARUNAVIR USING QBD APPROACH”. International Journal of Current Pharmaceutical Research, Vol. 10, no. 1, Jan. 2018, pp. 13-19, doi:10.22159/ijcpr.2018v10i1.24401.
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