Author(s):
Pooja L. Kumbhar, Anita S. Kulkarni, Rita D. Chakole, Manoj S. Charde
Email(s):
kumbhar18pooja@gmail.com
DOI:
10.52711/2231-5675.2024.00013 
Address:
Pooja L. Kumbhar*, Anita S. Kulkarni, Rita D. Chakole, Manoj S. Charde
Department of Pharmaceutical Chemistry, Government College of Pharmacy, Karad 415124, Maharashtra, India.
*Corresponding Author
Published In:
Volume - 14,
Issue - 2,
Year - 2024
ABSTRACT:
For the simultaneous estimation of Itraconazole (ITZ) and Terbinafine hydrochloride (TBF HCl) in tablet dosage form, a simple, novel, cost effective and rapid RP-HPLC method was developed. Method development becomes quick, accurate, sensitive, and robust by using quality by design (QbD). RP-HPLC was performed using a C18 (agilent, 4.6 x 250mm, 5µm particle size) column. Methanol and 0.05% OPA (pH 3.5) was used as mobile phase in 84:16 ratio. The analysis was conducted in gradient mode with a flow rate of 0.95mL/min. Detection wavelength was set at 270nm. Retention time for TBF and ITZ was at 2.93 and 6.96min, respectively. The accuracy, precision, repeatability, linearity, LOD, LOQ and robustness parameters have been validated as per the ICH Q2 (R1) guideline: Validation of analytical procedures–text and methodology. Values for LOD and LOQ were found to be 0.131 and 0.398µg/mL and 0.350 and 1.061µg/mL respectively for ITZ and TBF HCl. Thus, the technique can be employed for regular QC analysis of bulk ITZ and TBF HCl and their pharmaceutical formulations. Degradative stress conditions like acid, base, neutral, oxidation applied and degradations were studied.
Cite this article:
Pooja L. Kumbhar, Anita S. Kulkarni, Rita D. Chakole, Manoj S. Charde. QbD Approach to Method Development, Validation and Degradation Profiling of Antifungal Drugs by RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2024; 14(2):69-5. doi: 10.52711/2231-5675.2024.00013
Cite(Electronic):
Pooja L. Kumbhar, Anita S. Kulkarni, Rita D. Chakole, Manoj S. Charde. QbD Approach to Method Development, Validation and Degradation Profiling of Antifungal Drugs by RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2024; 14(2):69-5. doi: 10.52711/2231-5675.2024.00013 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2024-14-2-4
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