International Journal of Applied Science and Engineering
Published by Chaoyang University of Technology

Hiral N. Davea, Ashlesha G. Makwanab*, and Bhanubhai N. Suhagiac

aDepartment of Pharmaceutical chemistry, L. J. Institute of Pharmacy, Sanand Cross road, Ahmedabad, Gujarat, India
bDepartment of Pharmaceutical chemistry, K.B. Institute of Pharmaceutical Education and Research, GH/6, Sector-23, Gandhinagar, Gujarat, India
cDepartment of Pharmaceutical chemistry, L. M. College of Pharmacy, Opp. Gujarat University, Ahmedabad, Gujarat, India


 

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ABSTRACT


A simple and sensitive reversed phase high performance liquid chromatography (RP - HPLC) method has been proposed for determination of three widely used novel steroids in bulk as well as in their pressurized metered dose commercial preparations. The steroids are Budesonide, Fluticasone propionate and Ciclesonide. These steroids are widely used in treatment of different types of respiratory disorders mainly in the form of pressurized metered dose commercial formulations. The steroids were chromatographed using methanol: acetonitrile (60:40 v/v) as the mobile phase at a flow rate of 1.0 ml/min. The retention time (RT) of Budesonide, Fluticasone propionate and Ciclesonide was found to be 3.4161 ± 0.1305 min., 3.0512 ± 0.3694 min. and 4.841 ± 0.2421 min., respectively. The linearity of Budesonide, Fluticasone propionate and Ciclesonide were in the range of 1 - 10 µg/ml, 1 - 18 µg/ml and 2 - 20 µg/ml, respectively. The method was validated as per ICH guidelines and successfully applied for quantification of Budesonide, Fluticasone propionate and Ciclesonide in their pure and metered dose commercial formulations, contributing to improve the quality control and to assure the therapeutic efficacy.


Keywords: Budesonide; ciclesonide; fluticasone propionate; novel steroids; pressurized metered - dose preparations; reversed phase high performance liquid chromatography (RP - HPLC); analytical method validation


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ARTICLE INFORMATION


Received: 2012-08-01
Revised: 2012-11-03
Accepted: 2012-10-09
Available Online: 2013-06-01


Cite this article:

Dave, H.N., Makwana, A.G., Suhagia, B.N. 2013. Validated reversed phase high performance liquid chromatographic method for determination of three novel steroids in bulk and pressurized Metered-Dose commercial preparations using a common mobile phase. International Journal of Applied Science and Engineering, 11, 125–131. https://doi.org/10.6703/IJASE.2013.11(2).125