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Olanzapine Tablets

DEFINITION

Olanzapine Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of olanzapine (C17H20N4S).IDENTIFICATION

NFRAREDBSORPTIONStandard solution: 1 mg/mL of USP Olanzapine RS in chloroform

Sample solution: Dissolve a quantity of powdered Tablets, equivalent to 30 mg of olanzapine, in 30 mL of chloroform, and filter. Evaporate completely to dryness with the aid of a current of air. Redissolve the residue in 1 mL of chloroform.ASSAY

PROCEDURE

Buffer 1: 6.9 g/L of monobasic sodium phosphate. Adjust with phosphoric acid to a pH of 2.5.

Buffer 2: 12 g/L of sodium dodecyl sulfate in Buffer 1 Mobile phase: Acetonitrile and Buffer 2 (1:1)

System suitability solution: 0.1 mg/mL of USP Olanzapine RS and 0.01 mg/mL of USP Olanzapine Related Compound A RS in Mobile phase

Standard solution: 0.1 mg/mL of USP Olanzapine RS in Mobile phase

Sample solution: Transfer a known quantity of Tablets, equivalent to NLT 25 mg of olanzapine, to a suitable volumetric flask. Dilute with Mobile phase to volume, mix, and sonicate for 10 min. Centrifuge a portion of this solution, and dilute the clear supernatant with Mobile phase to obtain a solution containing about 0.1 mg/mL of olanzapine. [NOTE—Agitation of the flask may be necessary before sonication to prevent Tablets from adhering to the flask, making disintegration and dissolution difficult. ]

Chromatographic system (See .)Mode: LC

Detector: UV 260 nm

Column: 4.6-mm × 15-cm; 5-µm packing L7Flow rate: 1.5 mL/minInjection size: 20 µLSystem suitability

Samples: System suitability solution and Standard solution

[NOTE—The relative retention times for olanzapine related compound A and olanzapine are 0.89 and 1.0, respectively. ]