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  • 1 BITS Edu Campus, Vadodara-Mumbai NH #8, Varnama, Vadodara 391240, Gujarat, India
  • 2 Indukaka Ipcowala College of Pharmacy, New Vallabh Vidyanagar, Gujarat, India
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A sensitive and precise high-performance thin-layer chromatographic (HPTLC) method has been developed for the simultaneous estimation of clozapine and aripiprazole in combination. The method employed HPTLC aluminum plates pre-coated with silica gel 60 F254 as the stationary phase, while the solvent system was toluene‒methanol‒ethyl acetate‒ammonia (6.5:2.5:1:0.1, v/v). The R F values were observed to be 0.43 and 0.60 for clozapine and aripiprazole, respectively. Densitometric analysis was carried out in absorbance mode at 218 nm. The method was linear in the range of 200–1600 ng per band for clozapine and 100-800 ng per band for aripiprazole. The stress degradation study was performed, and it was found that clozapine was susceptible to acid hydrolysis, base hydrolysis, and photolytic degradation study. Aripiprazole was susceptible to oxidative stress degradation study. The method was validated and applied successfully for the estimation of both drugs in the synthetic mixture.

  • [1]

    Indian Pharmacopoeia, Ministry of Health and Family Welfare, Indian Pharmacopoeia Commission, Ghaziabad, 2014,vol. II, pp. 14481450, 1081.

  • [2]

    K.D. Tripathi , Essentials of medical pharmacology, 6th edn., Jaypee Brothers Medical Publishers Pvt. Ltd., New Delhi, 2005, pp. 424425.

    • Search Google Scholar
    • Export Citation
  • [3]

    “Aripiprazole augmentation for clozapine-treated patient with refractory schizophrenia”, Aug 2017; https://clinicaltrials.gov/ct2/show/NCT00328367.

  • [4]

    “Effectiveness of aripiprazole for improving side effects of clozapine in the treatment of people with schizophrenia”, Aug 2017; https://clinicaltrials.gov/ct2/show/NCT00345033.

  • [5]

    J.T. DiPiro , R.L. Talbert, G.C. Yee, G.R. Matzke, B.G. Wells, L.M. Posey, Pharmacotherapy, 6th edn., McGraw-Hill Medical Publishing Division, New Delhi, 1999, pp. 1209, 1215.

    • Search Google Scholar
    • Export Citation
  • [6]

    British Pharmacopoeia, The British Pharmacopoeia Commission, London, 2016, vol. I, pp. 194195, 610.

  • [7]

    United States Pharmacopeia and NationalFormulary, USP 32 NF, AsianEdition, The United States Pharmacopeial Convention, Rockville, MD, 2009, pp. 20062007.

  • [8]

    European Pharmacopoeia, Council of Europe, Strasbourg, 2005, vol. 5, pp. 13371338.

  • [9]

    T.A. Jennison , P. Brown, J. Crossett, M. Kushnir, F.M. Urry, J. Anal. Toxicol. 19 (1995) 537541.

  • [10]

    U. Patil , B. Ghosh, Int. J. PharmTech Res. 1 (2009) 733736.

  • [11]

    K. Manjunath , V. Vankateshwarlu, Indian J. Pharm. Sci. 67 (2005) 448452.

  • [12]

    M. Tyagi , Asian J. Biochem. Pharm. Res. 2 (2012) 4953.

  • [13]

    Z. Zhou , X. Li, K. Li, Z. Xie, Z. Cheng, W. Peng, F. Wang, R. Zhu, H. Li, J. Chromatogr. B 802 (2004) 25762.

  • [14]

    L. Mercolini , F. Bugamelli, E. Kenndler, G. Boncompagni, L. Franchini, M.A. Raggi, J. Chromatogr. B 846 (2007) 273280.

  • [15]

    A. Avenso , G. Facciola, M. Campo, A. Fazio, E. Spina, J. Chromatogr. B 714 (1998) 299308.

  • [16]

    P. Atodariya , H. Raj, V. Jain, PharmaTutor 3 (2015) 4148.

  • [17]

    R. Kalalchelvi , B. Thangabalan, R. Srinivasa, E. Jayachandran, E-J Chem. 6 (2009) 587590.

  • [18]

    J. Nagamallika , M. Aruna, Asian J. Pharm. Biol. Res. 1 (2011) 123128.

  • [19]

    S. Desai , C. Nitesh, P. Malairajan, R. Murugan, D.R. Chandra, A. Shafique, Int. J. Drug Dev. Res. 3 (2011) 205208.

  • [20]

    A.V. Subbayamma , C. Ramababu, Orient. J. Chem. 24 (2008) 677680.

  • [21]

    R. Jain , S.K. Kashaw, R. Jain, P. Mishra, V. Kohli, Int. J. Pharm. 73 (2011) 7476.

  • [22]

    A. Didamony , S. Hafeez, I. Ali, J. Appl. Pharm. Sci. 5 (2015) 2633.

  • [23]

    G. Ahmed , F. Abdelgawad, E. Mohamed, Asian J. Pharm. Anal. 2 (2012) 1219.

  • [24]

    B. Sastri , S. Gananadhamu, R. Devala, Asian J. Chem. 21 (2009) 66436646.

  • [25]

    M. Ashu , S. Parmar, K. Nagarajan, Med. Ugal. 17 (2012) 4953.

  • [26]

    B. Bhadru , P. Srinath, J. Kedarnath, Int. J. ChemTech Res. 4 (2012) 124128.

  • [27]

    N Ravindra , I. Shinghvi, G. Kumaraswamy, Indo Am. J. Pharm. Sci. 4 (2014) 18421849.

  • [28]

    N.R. Srinivasa , P. Srinivas, R. Venkateswara, Int. J. Adv. Pham. Biol. Chem. 1 (2012) 377380.

  • [29]

    K. Makwana , R. Dhamech, S. Kosalge, Int. J. Pharm. Pharm. Sci. 3 (2011) 121123.

  • [30]

    D. Patel , P. Sharma, M. Shrivastav, P. S. Shrivastav, J. Chromatogr. B 925 (2013) 2025.

  • [31]

    M. Kareem , Int. J. Pharm. Pharm. Sci. 6 (2014) 542548.

  • [32]

    N. Gandhi , D. Shah, D. Maheshwari, Int. J. Sci Res. 8 (2017) 1841318418.

  • [33]

    International Conference on Harmonization (ICH) Guideline Q2A (R1), Validation of analytical procedure, text and methodology Q2 (R1), Geneva, 2005.

  • [34]

    International Conference on Harmonization (ICH) Guideline Q1, Stability Testing of New Drug Substances and Products, Geneva, 1993.

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