International Journal of Pharmaceutical Investigation, 2023, 13, 3, 588-594.
DOI:10.5530/ijpi.13.3.073
Published: July 2023
Type: Original Article
Authors:
Hitesh G. Raval
[1]Research Scholar, Sankalchand Patel University, S.K. Campus, Kamana Cross Road, Visnagar, Gujarat, INDIA.[2]Department of Pharmaceutical Quality Assurance, Anand Pharmacy College, Anand, Gujarat, INDIA.
Ujashkumar A. Shah
Department of Quality Assurance and Pharmaceutical Chemistry, Nootan Pharmacy College, Sankalchand Patel University, S.K. Campus, Kamana Cross Road, Visnagar, Gujarat, INDIA.
Hirak Kumar Joshi
Department of Quality Assurance and Pharmaceutical Chemistry, Nootan Pharmacy College, Sankalchand Patel University, S.K. Campus, Kamana Cross Road, Visnagar, Gujarat, INDIA.
Vaishali T. Thakkar
Department of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, INDIA.
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.
Keywords: Simultaneous estimation, Fluconazole (FCZ), Quercetin (QCT), RP-HPLC, ICH Q2(R1) Guideline.