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- Title
Validated Reverse-Phase HPLC Method for Quantification of Fluconazole and Quercetin in Pharmaceutical Formulation.
- Authors
Raval, Hitesh G.; Shah, Ujashkumar A.; Joshi, Hirak Kumar; Thakkar, Vaishali T.
- Abstract
Objectives: Fluconazole (FCZ) and Quercetin (QCT) in pharmaceutical dosage form were simultaneously quantified using a sensitive, accurate, robust, and précised Reverse Phase-HPLC Method. Materials and Methods: RP-HPLC method was used to get the separation of FCZ and QCT using Imtakt® Unison-US-C18 column having a size of the particle, 5 µm (150 mm x 4.6 mm) operating at a 1.3 mL/min flow rate with an optimized mobile phase having Methanol-Water-Trifluoroacetic acid (TFA) in the proportion of 50:50:1%, v/v/v, respectively. The quantification of FCZ and QCT was done at 258 nm wavelength. Results and Discussions: In the developed method FCZ was retained at a retention time of 1.896 min, while QCT was retained at a retention time of 5.637 min. The proposed method separates FCZ and QCT with a resolution of 13.261. The validation of the method was done with reference to the guideline of ICH Q2(R1). FCZ and QCT showed linearity at 4-20 µg/mL, and 1-5 µg/mL, respectively. The % RSD for the precision study was less than 2 and recovery was in the range of 98.69% to 102.14% for both drugs. In the robustness study, the proposed method has less than 2 % RSD. Conclusion: The Method can be used to quantify Fluconazole and Quercetin simultaneously in a newly developed thermosensitive in-situ mucoadhesive vaginal gel formulation.
- Publication
International Journal of Pharmaceutical Investigation, 2023, Vol 13, Issue 3, p588
- ISSN
2230-973X
- Publication type
Academic Journal
- DOI
10.5530/ijpi.13.3.073