STABILITY INDICATING HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHIC DETERMINATION OF QUETIAPINE FUMARATE

A simple, sensitive, selective, precise and stability indicating high-performance thin-layer chromatographic method for determination of quetiapine fumarate both as a bulk drug and from tablets was developed and validated as per the International Conference on Harmonization (ICH) guidelines. The HPTLC method employed aluminum plates precoated with silica gel G 60F254 as stationary phase. The solvent system consisted of methanol: butanol: ethyl acetate (2:1:1) and give compact spots for quetiapine fumarate with Rf value 0.76 ± 0.01 cm. Densitometry analysis was carried out in the absorbance mode at 220 nm. Linear regression analysis showed good linearity (r² = 0.999) with respect to peak area in the concentration range of 1000–5000 ng/spot. The method was validated for precision, accuracy, specificity and robustness. The limits of detection and quantitation were 171.65 and 520.18 ng/spot, respectively. The method was validated for precision, accuracy, ruggedness and recovery. Quetiapine fumarate was subjected to acid and alkali hydrolysis, oxidation, thermal and photodegradation. The degraded products were well separated from the pure drug. The statistical analysis proves that the developed method for quantification of quetiapine fumarate as bulk drug and tablets was reproducible and selective. As the method could effectively separate the drug from its degradation products, it can be employed as stability-indicating one