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


R. D. Godambe, J. I. Disouza, C. M. Jamkhandi, P. S. Kumbhar

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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About this article

Title

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

Keywords

Spectrophotometry, Fluorometry, Darunavir, Condensation reaction

DOI

10.22159/ijcpr.2018v10i1.24401

Date

15-01-2018

Additional Links

Manuscript Submission

Journal

International Journal of Current Pharmaceutical Research
Vol 10, Issue 1 (Jan-Feb), 2018 Page: 13-19

Online ISSN

0975-7066

Authors & Affiliations

R. D. Godambe
Tatyasaheb Kore College of Pharmacy Warananagar, Dist: Kolhapur (MS) India
India

J. I. Disouza
Tatyasaheb Kore College of Pharmacy Warananagar, Dist: Kolhapur (MS) India
India

C. M. Jamkhandi
Tatyasaheb Kore College of Pharmacy Warananagar, Dist: Kolhapur (MS) India
India

P. S. Kumbhar
Tatyasaheb Kore College of Pharmacy Warananagar, Dist: Kolhapur (MS) India
India


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