DOI: http://dx.doi.org/10.18203/issn.2454-2156.IntJSciRep20210097

Analytical method development and validation studies for estimation of anti-psychotic drug (Olanzapine)

Renuka Manjunath, Deepak Kumar Jha

Abstract


Background: Various sophisticated strategies have been raised in conformity with permit the fast separation and quantification about clue aspects concerning complex mixtures of biological matrix. These needs underscored the necessary of analytical instrumentation and the creation of new strategies.

Methods: A rapid, accurate, precise, and simple UV then LC-MS/MS analytical methods has been flourished for the determination of Olanzapine (OLZ) in tablet formulation.  

Results: Chromatographic separation was conducted out on a Phenomenex 250×4.60 mm with an isocratic mobile phase consisting formic acid of 0.1% v/v in Methanol and water at a ratio regarding 92:08v/v and an aggregation run time of 2.5 min. The plasma Olanzapine concentrations were quantified the use of SCIEX API 3000 LC-MS/MS provision geared up along electro spray ionization cleft into the multiple reaction limit mode at m/z 313.4 to 256.3 for Olanzapine; and m/z 327.1 to 270.0 for clozapine respectively. Calibration requirements were organized into the range 5 ng/ml in conformity with 1000 ng/ml for Olanzapine. The effects had been unique and reproducible with the samples prepared by way of liquid-liquid extraction method using Tert-butyl methyl ether extraction in the course of approach improvement trials.

Conclusions: The novelty on its technique entails the improvement and validation by means of the usage of some quadrant easy pattern decontamination approach and the most sensitive technique with shortest analysis time.


Keywords


Bio-equivalence, LC-MS/MS, Matrix effects, Olanzapine

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