UV Spectrophotometric Method Development and Validation for Determination of an Antifungal Agent in Bulk and Capsules
Authors/Creators
- 1. Assistant Professor, Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, Andhra Pradesh, India
- 2. M. Pharmacy Student, Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, Andhra Pradesh, India
Description
A sensitive zero order UV spectroscopic method (Method A) and a first order derivative method (Method B) has been developed and validated for the determination of Itraconazole in formulations using phosphate buffer (pH 2.0). The drug showed maximum absorbance at 255nm (Method A) and amplitude was measured in the range of 245 nm-270 nm (Method B). Thedrug obeyed linearity in the range of 5–60 μg/mL. The present methods were validated as per International Conference on Harmonization guidelines. Percent recovery for Itraconazole in the range of 98- 101.66 % indicates accuracy and % RSD < 1.95 indicates precision of the methods. These methods can beconveniently used for the quality control analysis of Itraconazole in capsules without any interference from the excipients.
Files
(11-17)UV Spectrophotometric Method Development and Validation for Determination-format.pdf
Additional details
References
- Kent L.K., Wendel L.N., Evan D.K. et al. Stereo-chemical aspects of itraconazole metabolism in vitro and in vivo. Drug Metab Dispos. 2006; 34(4): pp. 583–90. Doi: https://doi.org/10.1124/dmd.105.008508.
- De Beule K., & Van GestelJ. Pharmacology of Itraconazole. Drugs. 2001; 61(1): pp. 27–37.
- Kumudhavalli M.V. Isocratic RP-HPLC, UV method development and validation of itraconazole in capsule dosage form. Int J Pharm Sci Res. 2011; 2(12): pp. 3269–71.
- Sarvani P. & HarithaPavani K. A new development and validated RP-HPLC method for the assay and related substances of itraconazole in capsule dosage form. Indian J. Res. Pharm. Biotechnol. 2013; 1(16): pp. 857–65.
- Kasagić I., Malenović A., Jovanović M. et al. Chemo-metrically assisted optimization and validation of RP-HPLC method for the analysis of itraconazole and its impurities. Acta Pharm. 2013; 63(2): pp. 159–73.
- Thangabalan B., Salomi M., Sunitha N. et al. Development of validated RP-HPLC method for the estimation of itraconazole in pure and pharmaceutical dosage form. Asian J. Pharm. Ana. 2013; 3(4): pp. 119–23.
- Trinadha Rao M., Vijaya Ratna J., Srinivas Rao Y. & Hemant Kumar T. Development and validation of RP-HPLC method for the determination of itraconazole in bulk and capsule dosage form. Int. J. Pharm. Sci. Rev. Res. 2015; 31(2): pp. 221–25.
- Manish KG, Sarika R. Development and validation of RP-HPLC method for quantitation of itraconazole in tablets dosage form. Int J Pharma Res. 2015; 4(11): 23 – 9.
- Sameer Al-Rawithi, Rajaa H., Ibrahim Al-Moshen, et al. Expedient microdetermination of itraconazole and hydroxyitraconazole in plasma by high-performance liquid chromatography with fluorescence detection. Ther. Drug Monit. 2001; 23(4): pp. 445–48.
- Shalin K.P., Jayant B.D., Chhagan N.P. et al. Stability-indicating high-performance thin-layer chromatographic method for analysis of itraconazole in bulk drug and in pharmaceutical dosage form. Pharm Methods. 2011; 2(2): pp. 88–94. Doi: 10.4103/2229-4708.84442.