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Chemometric Assisted Development and Validation of a Stability-indicating LC Method for Determination of Related Substances in Haloperidol Decanoate Injection

1,2, 1, 3, 2

  1. 1Vignan’s Foundation for Science, Technology and Research University, Vadlamudi, Guntur, Andhra Pradesh, INDIA.
  2. 2Department of Analytical Research and Development, Formulations, GVK Bio Sciences Pvt. Ltd., Mallapur, Hyderabad, Telanagana, INDIA.
  3. 3Department of Pharmaceutics, Vignan Pharmacy College, JNTU-Kakinada, Vadlamudi, Guntur, Andhra Pradesh, INDIA.

CORRESPONDENCE

Mr. Sudheer Babu Kolla

Vignan’s Foundation for Science, Technology and Research University, Vadlamudi, Guntur-522213, Andhra Pradesh, INDIA.

sudheer chowdary1979@gmail.com

Received: 27-02-2021; Accepted: 18-06-2021.

Volume 55, Issue 3 · pp. 904-915 · 2021 · DOI: 10.5530/ijper.55.3.165

ABSTRACT

Aim: Haloperidol decanoate injection is a phenyl butyl piperadine derivative with antipsychotic, neuroleptic, antiemetic effects and has multiple related substances as process and degradant impurities.Objectives: This study focuses on chemometric assisted liquid chromatographic approach to develop a stability indicating impurity profile of Haloperidol decanoate injection.Methodology: Dual experimental designs (combined mixture I-optimal design and response surface historical data design) were employed to resolve all thirteen known impurities of Haloperidol decanoate. Chromatographic separation was achieved on a Hypersil BDS C18 (100 x 4.0 mm) 3-µm column to attain separation of related compounds.Results: The optimum conditions for the chromatographic system resulted in a mobile phase consisting of tetra butyl ammonium hydrogen sulphate/ 1-decane Sulphonate sodium buffer solution and acetonitrile with linear gradient elution at a flow rate of 1.4 mL/min. Selectivity, forced degradation, linearity, accuracy and precision were demonstrated in a range of 0.75-30.0 µg/mL.Conclusion: The optimized method was able to resolve the ghost peak observed because of gradient change of mobile phase and is able to separate both polar and non-polar impurities within 60 min, in single method, with resolution of more than 2.0 between adjacent impurities. The inter-day precision for all impurities and haloperidol decanoate were evaluated and found to have a % RSD of less than 10.

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    Babu, S. K., Rao, M. V., Babu, S. P., & Chakka, M. V. V. S. (2021). Chemometric Assisted Development and Validation of a Stability-indicating LC Method for Determination of Related Substances in Haloperidol Decanoate Injection. Indian Journal of Pharmaceutical Education and Research, 55(3), 904-915. https://doi.org/10.5530/ijper.55.3.165

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    © 2021 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0