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
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.
 M. Raggi, G. Casamenti, R. Mandrioli, S. Fanali, D. De Ronchi, V. Volterra, Determination of the novel antipsychotic drug olanzapine in human plasma using HPLC with amperometric detection, Chromatographia 51(9-10) (2000) 562-566.
 S. Leucht, C. Corves, D. Arbter, R.R. Engel, C. Li, J.M. Davis, Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis, The Lancet 373(9657) (2009) 31-41.
 N. Bhana, C.M. Perry, Olanzapine: a review of its use in the treatment of bipolar I disorder, CNS drugs 15(11) (2001) 871-904.
 K. Pradhan, U. Mishra, S. Pattnaik, C. Panda, K. Sahu, Development and validation of a stability-indicating UV spectroscopic method for candesartan in bulk and formulations, Indian journal of pharmaceutical sciences 73(6) (2011) 693.
 K. Basavaiah, S.A. Abdulrahman, Sensitive and selective methods for the determination of olanzapine in pharmaceuticals using N-bromosuccinimide and two dyes, International Journal of ChemTech Research 2(1) (2010) 660-668.
 A. Krebs, B. Starczewska, H. Puzanowska-Tarasiewicz, J. Sledz, Spectrophotometric determination of olanzapine by its oxidation with N-bromosuccinimide and cerium (IV) sulfate, Analytical sciences 22(6) (2006) 829-833.
 D. Cui, Y. Li, M. Lian, F. Yang, Q. Meng, Development of a simple and stability-indicating RP-HPLC method for determining olanzapine and related impurities generated in the preparative process, Analyst 136(15) (2011) 3149-3156.
 C. D'Arrigo, G. Migliardi, V. Santoro, E. Spina, Determination of olanzapine in human plasma by reversed-phase high-performance liquid chromatography with ultraviolet detection, Therapeutic drug monitoring 28(3) (2006) 388-393.
 A. Pathak, S. Rajput, Development of a stability-indicating HPLC method for simultaneous determination of olanzapine and fluoxetine in combined dosage forms, Journal of chromatographic science 47(7) (2009) 605-611.
 K. Basavaiah, N. Rajendraprasad, K. Vinay, Isocratic High-Performance Liquid Chromatographic Assay of Olanzapine: Method Development and Validation, International Scholarly Research Notices 2014 (2014).
 A.R. Murthy, K.R. Babu, N. Vekariya, Analytical Method Development and Validation of Olanzapine by High Performance Liquid Chromatography, International Journal of Pharmaceutical Sciences and Drug Research 7(2) (2015) 188-192.
 R.N. Rao, A.N. Raju, R. Narsimha, G.R. Babu, Isolation and characterization of process related impurities of olanzapine using HPLC and ESI?MS/MS, Journal of separation science 31(1) (2008) 107-118.
 S. Niedermeier, G.K. Scriba, A quality by design-based approach to a capillary electrokinetic assay for the determination of dextromepromazine and levomepromazine sulfoxide as impurities of levomepromazine, Journal of pharmaceutical and biomedical analysis 146 (2017) 402-409.
 R. Peraman, K. Bhadraya, Y. Padmanabha Reddy, Analytical quality by design: a tool for regulatory flexibility and robust analytics, International journal of Analytical chemistry 2015 (2015).
 N. Khanam, M.I. Alam, Y. Ali, A. Siddiqui, A review on optimization of drug delivery system with experimental designs, Int J App Pharm 10(2) (2018) 7-12.
 T. Tome, N. Z?igart, Z. C?asar, A. Obreza, Development and optimization of liquid chromatography analytical methods by using AQbD principles: Overview and recent advances, Organic Process Research & Development 23(9) (2019) 1784-1802.
 I. Alam, N. Khanam, J.K. Shaikh, S. Ganguly, Quality by design-a recent trend in pharmaceutical industries, World J Pharm Res 5 (2016) 608-20.
 A. Tumpa, A. Staji?, B. Jan?i?-Stojanovi?, M. Medenica, Quality by design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine, Journal of pharmaceutical and biomedical analysis 134 (2017) 18-26.
 S. Naazneen, A. Sridevi, Development of assay method and forced degradation study of valsartan and sacubitril by RP-HPLC in tablet formulation, Int J App Pharm 9(1) (2017) 9-15.
This work is licensed under a Creative Commons Attribution 4.0 International License.