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Isolation and characterization of process related impurities of olanzapine using HPLC and ESI-MS/MS
Authors:Rao Ramisetti Nageswara  Raju Ale Narasa  Narsimha Ramaram  Babu Ganduri Raveendra
Affiliation:Analytical Chemistry Division, Discovery Laboratory, Indian Institute of Chemical Technology, Hyderabad, India. rnrao@iict.res.in
Abstract:An RP-HPLC method for the simultaneous separation and determination of olanzapine (OLZ) and its process impurities in bulk drugs and pharmaceutical formulations was developed. The separation was accomplished on Inertsil ODS 3V (4.6 mm x 250 mm; particle size 5 microm) column using 0.2 M ammonium acetate (pH = 4.50) and ACN as mobile phase in gradient elution mode. The analytes were monitored by a photo diode array (PDA) detector set at 254 nm and the flow rate was kept at 1.0 mL/min. The chromatographic behavior of all the compounds was examined under variable compositions of different solvents, buffer concentrations, and pH. The method was validated in terms of accuracy, precision, and linearity. Four unknown process impurities observed consistently during the analysis of different batches of OLZ were isolated and characterized by ESI-MS/MS, (1)H NMR, and FT-IR. The proposed RP-HPLC method was successfully applied to the analysis of commercial formulations. The method could be of use not only for rapid and routine evaluation of the quality of OLZ in bulk drug manufacturing units but also for the detection of its impurities in pharmaceutical formulations.
Keywords:Atypical antipsychotic  Isolation and characterization  Olanzapine  Schizophrenia  Process impurities
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