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Original Research Article
Development and Validation
of a Stability-Indicating LC-UV Method for Simultaneous
Determination of Ketotifen and Cetirizine in
Pharmaceutical Dosage Forms
Prachi V Kabra1*,
LVG Nargund1 and MS Murthy2
1Nargund College of
Pharmacy, Dattatreyanagar, IInd Main, 100ft. Ring Road,
BSK IIIrd Stage, Bangalore-560085, 2Vignan
Institute of Pharmaceutical Sciences, Vignan Hills,
Deshmuki Village, Pochampally Mdl, Nalgonda
District-508284, India
*For correspondence:
Email:
prachi.v.kabra@gmail.com
Received: 15 October 2013
Revised accepted: 10 May
2014
Tropical
Journal of Pharmaceutical Research, July 2014;
13(7): 1141-1147
http://dx.doi.org/10.4314/tjpr.v13i7.19
Abstract
Purpose: To develop and validate
stability-indicating reversed phase high performance
liquid chromatographic method for simultaneous
determination of ketotifen fumarate and cetirizine
dihydrochloride in solid dosage forms.
Method: Chromatographic separation
was achieved on Grace Smart C18 column (250 � 4.6 mm, 5
μm) using an isocratic mobile phase that consisted of
acetonitrile and 10 mM disodium hydrogen phosphate
buffer (pH 6.5) in a ratio of 45:55 % v/v at a flow rate
of 1 mL/min. Detection was carried out at 230 nm.
Salbutamol sulphate was used as an internal standard.
The drugs were exposed to hydrolytic (acid and
alkaline), oxidative, reductive and neutral stress
conditions, and the stressed samples analyzed by the
proposed method. Validation of the method was carried
out as per International Conference of Harmonization (ICH)
guidelines.
Results: The retention time for
ketotifen, salbutamol and cetirizine was 2.05, 5.37 and
6.77 min, respectively. In stress studies, it was
observed as cetirizine was more labile in acidic,
oxidative and neutral conditions than ketotifen. Both
the drugs were found comparatively stable in alkaline,
neutral condition and labile in reductive condition. The
method was linear in the concentration range of 1 - 30
μg/mL and 10 - 300 μg/mL for ketotifen and cetirizine,
respectively.
Conclusion: The developed method is
specific and stability-indicating as no interfering
peaks of degradants and excipients were observed. Thus,
the method is suitable for application in the
simultaneous quality control of both drugs.
Keywords: Ketotifen, Cetirizine,
Stability indicating method, Stressed conditions,
Validation |