Authors : Shabad Akshara; Bhavana Patil; Mahek Fatima; Palde Gayathri; Srinivas Chinta

Volume/Issue : Volume 11 - 2026, Issue 9 - September

Google Scholar : https://tinyurl.com/3rbc7pbt

DOI : https://doi.org/10.38124/ijisrt/26sep939

Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.

Abstract : Background: Itraconazole is a broad-spectrum triazole antifungal agent used in the management of various fungal infections. A simple, rapid and reliable analytical procedure is required for its routine quantitative determination in bulk drug and pharmaceutical dosage forms.  Objective: The present study aimed to develop and validate a UV–Visible spectrophotometric method for the quantitative determination of itraconazole in bulk drug and capsule dosage form.  Methods: The proposed method was developed using methanol as the solvent. Itraconazole exhibited maximum absorbance at 264 nm, which was selected as the analytical wavelength. The method was validated with respect to linearity, specificity, accuracy, precision and assay. Linearity was evaluated over the concentration range of 0.2–1.0 µg/mL. Quantification was performed using the calibration equation obtained from the relationship between concentration and absorbance.

Keywords : Itraconazole; UV–Visible Spectrophotometry; Method Development; Method Validation; Capsule Dosage form; Analytical Method; Pharmaceutical Analysis.

References :

1. Rao M, Trinidad R, Ratna J, Vijaya R, Rao Y, Srinivas. Development and validation of RP-HPLC method for the determination of itraconazole in bulk and capsule dosage form. International Journal of Pharmaceutical Sciences. 2015;31(2):221–225.
2. ChemicalBook. Itraconazole, CAS database record, CAS No. 8465-61-6.
3. National Center for Biotechnology Information. Itraconazole. PubChem Compound Summary, CID 3793.
4. Fischer J, Ganellin CR. Analogue-Based Drug Discovery. John Wiley & Sons; 2006. p. 503.
5. World Health Organization. WHO Model Lists of Essential Medicines: 21st List. 2019.
6. Denyer SP, Hodges N, Gorman SP, Gilmore BF. Hugo and Russell’s Pharmaceutical Microbiology. 8th ed. Wiley-Blackwell; 2011. p. 191–193.
7. O’Neil MJ. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals. Whitehouse Station, NJ: Merck & Co.; 2006. p. 907.
8. American Society of Health-System Pharmacists. Itraconazole. AHFS Drug Information. Accessed 8 December 2017.
9. Gilbert DN, Moellering RC, Eliopoulos GM, Sande MA. The Sanford Guide to Antimicrobial Therapy. 2006.
10. Rao M, Koteshware RKV, Reshana SR, Rao Narasimha D, Sujana DL. Method development and validation of itraconazole by UV spectrophotometer. World Journal of Pharmaceutical Research. 2014;3(10):777–787.
11. Sowjanya G, Sindhuri V. UV spectrophotometric method development and validation for determination of an antifungal in bulk capsule. Journal of Pharmaceutical Quality Assurance and Quality Control. 2019;1(1):11–17.
12. Tejaswani E, Puranik SB. Development and validation of itraconazole by instrumental methods in bulk and marketed formulation. Universal Journal of Pharmacy. 2018;7(4):7–20.
13. Salunke P, Ingale K, Gondhankheda P, Ghate K, Patil S. Visible spectrophotometry method development and validation of itraconazole in bulk and capsule formulation. Analytical International Journal in Pharmaceutical Analysis. 2017;9(1):45435–45439.
14. Parikh SK, Patel AD, Dave JB, Patel CN, Sen DJ. Development and validation of the UV spectrophotometric method for estimation of itraconazole bulk drug and pharmaceutical formulation. International Journal of Drug Development & Research. 2011;3(2):324–328.