Abstract
A rapid, selective and stability-indicating high performance thin layer chromatographic method was developed and validated for the simultaneous estimation of olanzapine and fluoxetine in combined tablet dosage form. Olanzapine and fluoxetine were chromatographed on silica gel 60 F254 TLC plate using methanol:toluene (4:2 v/v) as the mobile phase and spectrodensitometric scanning-integration was performed at a wavelength of 233 nm using a Camag TLC Scanner III. This system was found to give compact spots for both olanzapine (Rf value of 0.63±0.01) and fluoxetine (Rf value of 0.31±0.01). The polynomial regression data for the calibration plots showed good linear relationship with r2=0.9995 in the concentration range of 100-800 ng/spot for olanzapine and 1000-8000 ng/spot for fluoxetine with r2=0.9991. The method was validated in terms of linearity, accuracy, precision, recovery and specificity. The limit of detection and the limit of quantification for the olanzapine were found to be 30 and 100 ng/spot, respectively and for fluoxetine 300 and 1000 ng/spot, respectively. Olanzapine and fluoxetine were degraded under acidic, basic and oxidation degradation conditions which showed all the peaks of degraded product were well resolved from the active pharmaceutical ingredient. Both drugs were not further degraded after thermal and photochemical degradation. The method was found to be reproducible and selective for the simultaneous estimation of olanzapine and fluoxetine. As the method could effectively separate the drugs from their degradation products, it can be employed as a stability-indicating method.
Highlights
At time intervals of 0, 30, 60, 90, 120, 180 and 360 minutes, 2.5 ml of the solution was transferred in series of 25 ml of volumetric ßasks and diluted to the mark with mobile phase to stop further degradation
99.96 precision was determined by analyzing standard solutions in the concentration range of 200 ng/spot to 500 ng/spot for olanzapine and 2000 ng/spot to
Degradation studies indicate that olanzapine and ßuoxetine showed good degradation in acidic and basic condition, which started to degrade after 30 min and continued up to 180 min
Summary
Weighed olanzapine (50 mg) and ßuoxetine (500 mg) was transferred in 50 ml of volumetric ßask and dissolved in methanol (25 ml). At time intervals of 0, 30, 60, 90, 120, 180 and 360 minutes, 2.5 ml of the solution was transferred in series of 25 ml of volumetric ßasks and diluted to the mark with mobile phase to stop further degradation. The LOD and LOQ for olanzapine was found to be 30 and 100 ng/spot and for ßuoxetine, 300 and 1000 ng/spot respectively.
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