Stability-indicating high-performance liquid chromatography (HPLC) method development and validation for the determination of quetiapine fumarate in bulk and dosage form by HPLC

S. G. Talele


Objective: The purpose of the realistic study is the determination of Quetiapine fumarate in bulk and tablet dosage form utilizing a basic, particular, exact, and formalize stability signifying high-performance liquid chromatography (HPLC) method. Materials and Methods: The assessment of Quetiapine fumarate in tablet dosage form performed using a validated stability-indicating HPLC method. HPLC Binary Gradient System of model no. HPLC 3000 Series having Greece C18 (250 mm × 4.6 ID, Particle size: 5 micron) column using mobile phase composition of methanol:water (80:20) is used and pH was adjusted to 3. Flow rate was maintained at 0.9 ml/min at room temperature. Evaluation was accomplished with ultraviolet detection at 213 nm. Results and Discussion: The retention time acquired for Quetiapine fumarate was at 3.3 min. The result acquired with the detector response was found to be linear which is in the concentration range of 20–100 μg/ml. This technique has been accepted and appeared to be particular, delicate, exact, straight, precise, rough, vigorous, and quick. Quetiapine fumarate was subjected to different accelerated stress conditions. The degradation products when anywhere well resolved from the pure drug with significantly different retention time values. Conclusion: It is inferred that this system can be connected for routine quality control of Quetiapine fumarate in tablet dosage forms as well as in bulk drug.

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