Ion-pair RP-HPLC method for the estimation of eberconazole nitrate in bulk form and in pharmaceutical dosage forms

• Autorzy: Vamsi Krishna M. , Dash R. N. , Jalachandra Reddy B. , Venugopal P. , Sandeep P. , Madhavi G.
• Języki publikacji: EN

Abstrakty

EN

An isocratic ion-pair reversed phase high-performance liquid chromatography-ultraviolet (RP-HPLC-UV) method for analysis of eberconazole nitrate in bulk and in pharmaceutical dosage forms has been developed and validated. Best separation was achieved on Lichrospher C18 column (250 mm × 4.6 mm, 5 μm) using a mobile phase of 10 mM potassium dihydrogen phosphate containing 10 mM tetra-butyl ammonium hydroxide (pH adjusted to 2.8 with ortho phosphoric acid) and methanol (75:25, v/v) at a flow rate of 1.0 mL min^-1. UV detection was performed at 220 nm. The method was validated for specificity, linearity, precision, accuracy, limit of detection, limit of quantification, robustness, and solution stability. The calibration plot was linear over the concentration range of 10–80 μg mL^-1 (r2 = 0.999) and the limits of detection and quantification were 0.3 and 0.9 μg mL^-1, respectively. Intra-day and inter-day precisions were 1.13% and 1.67%, respectively. Experimental design was employed to optimize the method. The method was successfully used for analysis of eberconazole nitrate in commercially available cream (Ebernet).

Słowa kluczowe

EN

eberconazole nitrate; ion-pair RP-HPLC; method validation; pharmaceutical dosage forms

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2013
• Tom: Vol. 25, no. 3
• Strony: 503--518
• Opis fizyczny: Bibliogr. 6 poz., rys., tab.

Twórcy

autor

Vamsi Krishna M.

• Alliance Institute of Advanced Pharmaceutical and Health Sciences Ameerpet, Hyderabad 500038 Andhra Pradesh India

autor

Dash R. N.

• Alliance Institute of Advanced Pharmaceutical and Health Sciences Ameerpet, Hyderabad 500038 Andhra Pradesh India

autor

Jalachandra Reddy B.

• Alliance Institute of Advanced Pharmaceutical and Health Sciences Ameerpet, Hyderabad 500038 Andhra Pradesh India

autor

Venugopal P.

• Alliance Institute of Advanced Pharmaceutical and Health Sciences Ameerpet, Hyderabad 500038 Andhra Pradesh India

autor

Sandeep P.

• Alliance Institute of Advanced Pharmaceutical and Health Sciences Ameerpet, Hyderabad 500038 Andhra Pradesh India

autor

Madhavi G.

• Alliance Institute of Advanced Pharmaceutical and Health Sciences Ameerpet, Hyderabad 500038 Andhra Pradesh India

Bibliografia

• [1] S.C. Sweetman, Martindale: The Complete Drug Reference, 36th edn., Pharmaceutical Press, London, 2009, 530
• [2] M.J. Barbanoj, R. Antonijoan, C. Garcia-Gea, M. Puntes, I. Gich, and F. Jane, Methods Find. Exp. Clin. Pharmacol., 27, 227 (2005)
• [3] M. Torres-Rodríguez, R. Mendez, O.L. Jodra, Y. Morera, M. Espasa, T. Jimenez, and C. Lagunas, Antimicrob. Agents Chemother., 43, 1258 (1999)
• [4] R.J. Ekiert, J. Krzek, and P. Talik, Talanta, 82, 1090 (2010)
• [5] StatSoft, Inc., Statistica Data Analysis System, Statistica Software, Tulsa, OK, 2001
• [6] International Conference on Harmonization (ICH), Validation of Analytical Procedures: Text and Methodology Q2 (R1), Geneva, 2005