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A Qbd Driven Approach for Development and Validation of an RP-UHPLC Method for Simultaneous Estimation of Ofloxacin and Fluconazole: An Application to Pharmaceutical Analysis

A Qbd Driven Approach for Development and Validation of an RP-UHPLC Method for Simultaneous... Abstract A simple reverse-phase UHPLC (RP-UHPLC) analytical method was developed and validated according to International Council on Harmonization (ICH) guidelines for simultaneous estimation of ofloxacin (OFX) and fluconazole (FCZ) using a Response surface aided central composite design (CCD, Design-Expert®, Version 11.1.2.0). The method was validated for linearity, selectivity, sensitivity, accuracy, precision, limits of detection and quantification, solution stability and robustness. OFX and FCZ separation were achieved using Agilent 1290 Infinity II UHPLC system encompassed with Waters Atlantis® T3 (150 × 4.6 mm2 i.d., 3 µm particle size) column, water containing 0.1% v/v formic acid and methanol as isocratic mobile phase. OFX and FCZ eluted at 4.1 and 10.5 min with no interference of the excipients used in formulation at λmax 260 nm. The developed method was envisaged to determine total drug content, in vitro drug release study and ex-vivo corneal permeation study of conventional as well as novel drug delivery formulations. The proposed method is simple, cost-effective, dependable and reproducible and could be used for the regular analysis of OFX and FCZ in bulk and quality controls in the research and pharmaceutical industries. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

A Qbd Driven Approach for Development and Validation of an RP-UHPLC Method for Simultaneous Estimation of Ofloxacin and Fluconazole: An Application to Pharmaceutical Analysis

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A Qbd Driven Approach for Development and Validation of an RP-UHPLC Method for Simultaneous Estimation of Ofloxacin and Fluconazole: An Application to Pharmaceutical Analysis

Abstract

Abstract A simple reverse-phase UHPLC (RP-UHPLC) analytical method was developed and validated according to International Council on Harmonization (ICH) guidelines for simultaneous estimation of ofloxacin (OFX) and fluconazole (FCZ) using a Response surface aided central composite design (CCD, Design-Expert®, Version 11.1.2.0). The method was validated for linearity, selectivity, sensitivity, accuracy, precision, limits of detection and quantification, solution stability and robustness....
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Publisher
Taylor & Francis
Copyright
© 2022 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2022.2063069
Publisher site
See Article on Publisher Site

Abstract

Abstract A simple reverse-phase UHPLC (RP-UHPLC) analytical method was developed and validated according to International Council on Harmonization (ICH) guidelines for simultaneous estimation of ofloxacin (OFX) and fluconazole (FCZ) using a Response surface aided central composite design (CCD, Design-Expert®, Version 11.1.2.0). The method was validated for linearity, selectivity, sensitivity, accuracy, precision, limits of detection and quantification, solution stability and robustness. OFX and FCZ separation were achieved using Agilent 1290 Infinity II UHPLC system encompassed with Waters Atlantis® T3 (150 × 4.6 mm2 i.d., 3 µm particle size) column, water containing 0.1% v/v formic acid and methanol as isocratic mobile phase. OFX and FCZ eluted at 4.1 and 10.5 min with no interference of the excipients used in formulation at λmax 260 nm. The developed method was envisaged to determine total drug content, in vitro drug release study and ex-vivo corneal permeation study of conventional as well as novel drug delivery formulations. The proposed method is simple, cost-effective, dependable and reproducible and could be used for the regular analysis of OFX and FCZ in bulk and quality controls in the research and pharmaceutical industries.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: May 4, 2022

Keywords: Fluconazole; Ofloxacin; RP-UHPLC; Quality by design; Validation

References

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