A A NEW METHOD BASED ON AN INNOVATIVE WINDOW ASSISTED BOX-BEHNKEN DESIGN AND REVERSED-PHASE HPLC-UV FOR THE IDENTIFICATION OF AN ANTIPSYCHOTIC MEDICATION OLANZAPINE AND ITS FORCED DEGRADATION STUDIES IN PURE DRUG

  • IRSHAD ALAM Faculty of Science and Technology, Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, Maharashtra, India
  • AQUIL-UR-RAHIM SIDDIQUI Shri Bhagwan College of Pharmacy affiliated to Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, Maharashtra, India

Abstract

In the present work, an innovative window assisted Box-Behnken design and reversed-phase high performance liquid chromatography-ultraviolet (HPLC-UV) method was developed and validated for the identification of an antipsychotic medication Olanzapine and its organic impurities in pure drug along with forced degradation studies. The chromatographic conditions comprised an Inertsil ODS 3V analytical column with dimension 250 mm x 4.6 mm and particle size 5µm. The isocratic mobile phase was used as a mixture of monobasic sodium phosphate buffer (0.01 M, pH 6), methanol and acetonitrile in the proportion of 40/30/30, v/v. The mobile phase flow rate and UV λmax was 1 mL/min and 260 nm, respectively. The method was optimized by Box-Behnken design using design expert software, comprising of three factors for Olanzapine for instance flow rate (A), mobile phase composition (B) and pH (C) while resolution between Olanzapine related compound A and Olanzapine related compound B (Y1) and tailing of Olanzapine (Y2) were taken as response. The excellent quality parameters were achieved in terms of linearity with coefficient of correlation (R2>0.9999), limit of detection (LOD, 0.0023-0.16 µg/mL), limit of quantification (LOQ, 0.007-0.39 µg/mL), accuracy (99-100%) and precision ((2%, relative standard deviation (%RSD) were evaluated as per latest available procedures. Forced degradation conditions were carried out, demonstrated that the optimized method was stable and no any interfering peaks eluting at the similar retention time of the studied compounds. The method was found to be stable, easy, rugged and robust, could be applied for the similar types of the pure drug.

Keywords: Olanzapine; forced degradation; Box-Behnken design; Experimental design; HPLC-UV

References

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ALAM, I., & SIDDIQUI, A.-U.-R. (2021). A A NEW METHOD BASED ON AN INNOVATIVE WINDOW ASSISTED BOX-BEHNKEN DESIGN AND REVERSED-PHASE HPLC-UV FOR THE IDENTIFICATION OF AN ANTIPSYCHOTIC MEDICATION OLANZAPINE AND ITS FORCED DEGRADATION STUDIES IN PURE DRUG. International Journal of Applied Pharmaceutics, 13(4). https://doi.org/10.22159/ijap.2021v13i4.41427
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