Stability-indicating simultaneous HPTLC method for olanzapine and fluoxetine in combined tablet dosage form

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.

Development of a stability-indicating UPLC method for determining olanzapine and its associated degradation products present in active pharmaceutical ingredients and pharmaceutical dosage forms

“…Specificity is the ability of the method to measure the analyte response in the presence of its potential impurities [17]. The specificity of the developed LC method for OLN was carried out in the presence of its eight impurities.…”

Validated Stability-Indicating UPLC Method for Determination of Dapoxetine and Fluoxetine: Characterization of Their Hydrolytic Degradation Products, Kinetic Study and Application in Pharmaceutical Dosage Forms

“…In the literature survey, few methods have been developed for the stability indicating assay of FLX in combination with other drugs including; HPTLC densitometry [24] and HPLC via diode array detection [25] and UV detection [26].…”

“…In addition, no data published for identification and characterization of FLX degradation products [24][25][26].…”

Stability-indicating methods for the determination of olanzapine in presence of its degradation products

“…spectrophotometric [16][17][18], and fluorimetric [18] methods. OLA can also be determined by electrochemical methods [17,18], capillary electrophoresis [19], and thin layer chromatography [20][21][22][23][24]. High performance liquid chromatographic [HPLC] methods were widely used for analysis of OLA in pure form .…”