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Research Article

Simultaneous estimation of raloxifene and cladrin by HPLC: application to metabolic stability studies in different species

    Divya Chauhan

    Division of Pharmaceutics & Pharmacokinetics, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, 226031, India

    Academy of Scientific & Innovative Research (AcSIR), Ghaziabad, 201002, India

    ,
    Pavan K Yadav

    Division of Pharmaceutics & Pharmacokinetics, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, 226031, India

    Academy of Scientific & Innovative Research (AcSIR), Ghaziabad, 201002, India

    ,
    Nazneen Sultana

    Division of Pharmaceutics & Pharmacokinetics, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, 226031, India

    ,
    Arun Agarwal

    Division of Pharmaceutics & Pharmacokinetics, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, 226031, India

    Academy of Scientific & Innovative Research (AcSIR), Ghaziabad, 201002, India

    ,
    Shailesh Dadge

    Division of Pharmaceutics & Pharmacokinetics, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, 226031, India

    Academy of Scientific & Innovative Research (AcSIR), Ghaziabad, 201002, India

    ,
    Naveen Singh

    Division of Pharmaceutics & Pharmacokinetics, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, 226031, India

    ,
    Debalina Maity

    Division of Pharmaceutics & Pharmacokinetics, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, 226031, India

    ,
    Manish K Chourasia

    Division of Pharmaceutics & Pharmacokinetics, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, 226031, India

    Academy of Scientific & Innovative Research (AcSIR), Ghaziabad, 201002, India

    &
    Jiaur R Gayen

    *Author for correspondence: Tel.: +91 522 277 2450;

    E-mail Address: jr.gayen@cdri.res.in

    Division of Pharmaceutics & Pharmacokinetics, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, 226031, India

    Academy of Scientific & Innovative Research (AcSIR), Ghaziabad, 201002, India

    Published Online:https://doi.org/10.4155/bio-2023-0046

    Aim: A reliable, sensitive, HPLC method was developed and validated to simultaneously quantify raloxifene (RLX) and cladrin (CLD). Method: The C18 column was used to analyze RLX and CLD at λmax 285 and 249 nm. The mobile phase was composed of acetonitrile and 35:65% v/v aqueous solution of 0.1% formic acid. Results: The method was linear over the linearity range of 0.078–20 μg/ml, and the limit of detection and limit of quantification for RLX and CLD were 0.191 and 0.228 and 0.581 and 0.69 μg/ml, respectively. Conclusion: In accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, the developed method is precise and accurate for simultaneous estimation of RLX and CLD with applications in in vitro liver microsomal stability in mice, rabbits, dogs, monkeys and humans.

    Papers of special note have been highlighted as: • of interest; •• of considerable interest

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