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Application of analytical quality by design approach in method development for the simultaneous estimation of levocetrizine hydrochloride and montelukast sodium in their combined dosage form

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Abstract

This paper deals with chromatographic method development for the simultaneous estimation of levocetrizine hydrochloride and montelukast sodium in their combined dosage form using analytical quality by design approach. The main objective for application of analytical quality by design approach was to identify conditions where an adequate separation could be achieved within a robust region. Critical method parameters that have the most influence on resolution and retardation factors of both drugs are volume of methanol and volume of modifier (triethylamine); these critical parameters were screened by using Taguchi orthogonal array (OA) design from the seven potential method parameters. Further 32 factorial design was used for establishing the relationship between critical process parameters: volume of methanol and volume of modifier (triethylamine) on critical quality attributes: resolution and retardation factors of both drugs. The chromatographic separation was performed using aluminium backed pre-coated silica gel 60 F254 as stationary phase and ethyl acetate:methanol:triethylamine (5:5:0.04, % v/v) as the mobile phase. The quantification was carried out at 234 nm wavelength. The Rf values were found to be 0.23 ± 0.02 and 0.55 ± 0.02 for levocetrizine hydrochloride and montelukast sodium, respectively. The method was validated as per ICH Q2(R1) guidelines where the method was found to be specific, linear, precise, robust and accurate in the range of 100–500 ng/band for levocetrizine hydrochloride and 200–1000 ng/band for montelukast sodium. The developed HPTLC method was successfully applied for the routine analysis of levocetrizine hydrochloride and montelukast sodium in their combined tablet dosage form.

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Authors and Affiliations

  1. Maliba Pharmacy College, Uka Tarsadia University, Maliba Campus, Gopal Vidyanagar, Bardoli, Gujarat, 394350, India

    Jina A. Desai, Praful P. Dedhiya, Hitika B. Patel, Ashish D. Mishra & Shailesh A. Shah

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  1. Jina A. Desai
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  2. Praful P. Dedhiya
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  3. Hitika B. Patel
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  4. Ashish D. Mishra
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  5. Shailesh A. Shah
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Correspondence to Praful P. Dedhiya.

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Desai, J.A., Dedhiya, P.P., Patel, H.B. et al. Application of analytical quality by design approach in method development for the simultaneous estimation of levocetrizine hydrochloride and montelukast sodium in their combined dosage form. JPC-J Planar Chromat 33, 119–129 (2020). https://doi.org/10.1007/s00764-020-00019-y

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  • DOI: https://doi.org/10.1007/s00764-020-00019-y

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