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Validated Stability-Indicating Method for Alendronate Sodium Employing Zwitterionic Hydrophilic Interaction Chromatography Coupled with Charged Aerosol Detection

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Abstract

Alendronate sodium is widely used in the treatment of osteoporosis and Paget’s disease. The HPLC method development for alendronate sodium, in particular, is challenging owing to the absence of chromophoric group and its high polarity. In the present study, a short and simple isocratic method was developed involving hydrophilic interaction liquid chromatography, coupled with a charged aerosol detector. The developed method was validated according to the ICH Q2(R1) guideline and was successfully applied for the analysis of a marketed formulation containing the drug.

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Authors and Affiliations

  1. Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar, Mohali, 160062, Punjab, India

    Surapuraju Pavan Kumar Raju, Mallikarjun Narayanam, Banothu Kranthi Kumar, Sreeram Tejaswee & Saranjit Singh

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  1. Surapuraju Pavan Kumar Raju
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  2. Mallikarjun Narayanam
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  3. Banothu Kranthi Kumar
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  4. Sreeram Tejaswee
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  5. Saranjit Singh
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Correspondence to Saranjit Singh.

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Raju, S.P.K., Narayanam, M., Kumar, B.K. et al. Validated Stability-Indicating Method for Alendronate Sodium Employing Zwitterionic Hydrophilic Interaction Chromatography Coupled with Charged Aerosol Detection. Chromatographia 78, 1245–1250 (2015). https://doi.org/10.1007/s10337-015-2941-8

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  • DOI: https://doi.org/10.1007/s10337-015-2941-8

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