DEVELOPMENT AND VALIDATION OF REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF OLANZAPINE AND ARIPIPRAZOLE IN SYNTHETIC MIXTURES

MEGHA PATEL; PARESH PATEL; DHARA PATEL

doi:10.22159/ajpcr.2020.v13i8.38278

Authors

MEGHA PATEL Department of Pharmacy, Ganpat University, Kherva, Gujarat, India.
PARESH PATEL Department of Pharmaceutical Chemistry, Ganpat University, Kherva, Gujarat, India.
DHARA PATEL Department of Pharmaceutical Quality Assurance, Pioneer Pharmacy Degree College, Vadodara, Gujarat, India.

DOI:

https://doi.org/10.22159/ajpcr.2020.v13i8.38278

Keywords:

Olanzapine, Aripiprazole, Reverse-phase high-performance liquid chromatography, Validation

Abstract

Objective: A simple, rapid, accurate, precise, specific, and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated for simultaneous estimation of olanzapine (OLZ) and aripiprazole (APR) in synthetic mixtures.

Methods: The stationary phase used for chromatographic separation was Phenomenex C18 column (250 mm × 4.6 mm i.d, particle size 5 μm) and mobile phase used for separation was methanol: Phosphate buffer (pH 3) taken in ratio of 75:25 %v/v. The flow rate was used 1.0 ml/min at room temperature and drugs detected at 240 nm with injection volume 20 μL.

Results: The retention time for OLZ and APR was found to be 4.231 and 6.523 min, respectively. The linearity was performed using a concentration range of 0.5–3.0 for both drugs. The correlation coefficient was found to be 0.999 for OLZ and APR. The % purity of both the drug was found to be 98–102%. The proposed RP-HPLC method has been validated, according to International council on harmonization Q2 (B) guidelines.

Conclusion: There was no interference of any diluents and excipients in the determination of drugs from synthetic mixture. Hence, the developed method can be used for routine quality control analysis.

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