Open Access Open Access  Restricted Access Subscription Access

UV Spectrophotometric Method Development and Validation for Determination of an Antifungal Agent in Bulk and Capsules

Sowjanya Gummadi, Sindhuri Varanasi

Abstract


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.


Full Text:

PDF

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.

El-Enany N., El-Sherbilny D. & Belal F. Spectro-fluorimetric determination of itraconazole in dosage forms and spiked human plasma. J. Chin. Chem. Soc. 2007; 54: pp. 375–82.

Kousoulos C., Tsatsou G., Apostolou C., Dotsikas Y. & Loukas Y.L. Development of a high-throughput method for the determination of itraconazole and its hydroxy metabolite in human plasma, employing automated liquid-liquid extraction based on 96-well format plates and LC/MS/MS. Anal. Bioanal. Chem. 2006; 384(1): pp. 199–207.

Radosław J.E. & Jan K. Determination of azole antifungal medicines using zero-order and derivative UV spectrophotometry. Acta Pol Pharm Drug Res. 2009; 66(1): pp. 19–24.

Shalin K.P., Ankit D.P., Dave J.B. et al. Development and validation of UVspectrophotometric method for estimation of itraconazole bulk drug and pharmaceutical formulation. IJDDR. 2011; 3(2): pp. 324–28.

Koteswara Rao M., Ramanjaneyulu K.V., Reehana S.k. et al. Method development and validation of itraconazole by UV Spectrophotometer. World J Pharm Res. 2014; 3(10): pp. 777–87.

Soundarya G., Venkateswara Rao P., Chandrika Ch. et al. Method development and analytical method validation of itraconazole by using UV- Visible Spectrophotometry. Indo Am. J. Pharm. Sci. 2016; 3(5): pp. 487–91.

Asma A.P., Prasad R.D., Pappu M.T. et al. Development and validation of UV spectrophotometric method for quantitation of itraconazole from its capsule dosage form. IJCPA. 2017; 4(2): pp. 1–9.

Poonam A.S., Kamlesh I., Pooja G. et al. UV-Visible spectrophotometric method development and validation of itraconazole in bulk and capsule formulation. Int J Curr Res. 2017; 9(1): pp. 45435–39.

ICH Harmonized Tripartite Guidelines, Validation of Analytical Procedures: Text and Methodology Q2 (R1), Nov. 2005.


Refbacks

  • There are currently no refbacks.