Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
47, Number 7, August 2009, pp. 605-611
Development of a Stability-Indicating HPLC Method
for Simultaneous Determination of Olanzapine and Fluoxetine in
Combined Dosage Forms
A. Pathak and S.J. Rajput
Quality Assurance Laboratory, Centre of Relevance and Excellence
in Novel Drug Delivery System, Pharmacy Department, G.H. Patel Building,
Donor’s Plaza, The Maharaja Sayajirao University of Baroda, Fatehgunj,
Vadodara, Gujarat, India – 390 002
A stability-indicating high-performance liquid
chromatography method is developed for analysis of olanzapine
and fluoxetine in the presence of their degradation products
generated from forced decomposition studies as prescribed by
the International Conference on Harmonization. Hydrolysis, oxidation,
photolysis, and thermal degradation are evaluated by subjecting
the drug substances to stress conditions. Successful separation
of drugs from degradation products is achieved on a reversed-phase
C18 column using 75 mM potassium dihydrogen phosphate
buffer (pH 4.0)–acetonitrile–methanol (55:40:5, v/v/v)
as the mobile phase. The flow rate is 0.8 mL/min, and the detection
wavelength is 227 nm. The method is validated with respect to
linearity, precision, accuracy, system suitability, and robustness.
The utility of the procedure is verified by its application to
marketed formulations that are subjected to accelerated stability
studies. Good separation of the drugs and their degradation products
is observed using this method. The products formed in marketed
tablet dosage forms are similar to those formed in standard drug
solutions under similar stress conditions.
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