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Stability-indicating HPTLC method development for determination of arterolane maleate and piperaquine phosphate in combined dosage form

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Abstract

A stability-indicating high-performance thin-layer chromatography (HPTLC) method was developed and validated for determination of arterolane maleate and piperaquine phosphate in combined dosage form. This study was carried out by using the mobile phase containing isopropyl alcohol:n-butanol:methanol:triethylamine (3:6:1:0.2 v/v). The method was validated as per the International Conference on Harmonization (ICH) guidelines. The correlation coefficient was found to be 0.9961 and 0.9914 in the concentration range of 150–900 and 750–4500 ng/band for arterolane maleate and piperaquine phosphate, respectively. The method had an accuracy of 98.25% for arterolane maleate and 97.15% for piperaquine phosphate. For stability study, arterolane maleate and piperaquine phosphate were subjected to acid, base, oxidation, heat, and photo-degradation studies. As the HPTLC method could effectively separate the drugs from their degradation products, it can be used for stability-indicating analysis.

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Acknowledgments

The authors would like to thank to Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune, and also Sinhgad Institute of Pharmacy, Narhe, for providing the necessary infrastructural facilities to perform this study.

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Authors and Affiliations

  1. Department of Pharmaceutical Chemistry, Sinhgad Institute of Pharmacy, Narhe, Pune, Maharashtra, 411041, India

    Shubhangee Gaikwad, Amol Bansode & Shraddha Tathe

  2. Department of Quality Assurance Techniques, Sinhgad Institute of Pharmacy, Narhe, Pune, India

    Nisha Patade

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  1. Shubhangee Gaikwad
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  2. Amol Bansode
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  3. Nisha Patade
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  4. Shraddha Tathe
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Correspondence to Shubhangee Gaikwad.

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Gaikwad, S., Bansode, A., Patade, N. et al. Stability-indicating HPTLC method development for determination of arterolane maleate and piperaquine phosphate in combined dosage form. JPC-J Planar Chromat 33, 131–139 (2020). https://doi.org/10.1007/s00764-020-00021-4

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  • DOI: https://doi.org/10.1007/s00764-020-00021-4

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