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  • P-ISSN 1225-0163
  • E-ISSN 2288-8985

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    Development of official assay method for loperamide hydrochloride capsules by HPLC

    Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
    2020, v.33 no.6, pp.252-261
    https://doi.org/10.5806/AST.2020.33.6.252
    Thi-Anh-Tuyet Le (College of Pharmacy, Kangwon National University)
    Bao-Tan Nguyen (College of Pharmacy, Kangwon National University)
    Min-Ho Kim (College of Pharmacy, Kangwon National University)
    Bit Kim (College of Pharmacy, Kangwon National University)
    Hyun-Soo Kim (College of Pharmacy, Kangwon National University)
    Seung-Won Jeong (College of Pharmacy, Kangwon National University)
    Jong-Seong Kang (College of Pharmacy, Chungnam National University)
    Dong-Hee Na (College of Pharmacy, Chungang University)
    In-Koo Chun (The Research Foundation for Pharmaceutical Quality)
    Kyeong Ho Kim (College of Pharmacy, Kangwon National University)
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    Abstract

    Currently, the potentiometric titration and the high pressure liquid chromatography (HPLC) method were utilized in Korean Pharmacopoeia XII (KP XII) as well as other pharmacopoeias (USP, EP, BP) for determination of loperamide hydrochloride in raw materials and capsules, respectively. The research objective is to overcome the remaining drawbacks from current methods such as solubility of mobile phase (KP XII), less scientific approach (USP 43) or using paired-ion chromatography reagent which shows some limitations (BP2017 and other formulation monographs). The proposed method was optimized by Design of Experiment (DoE) tool to obtain the satisfied method for determination of loperamide hydrochloride. The optimal condition was performed on the common C18 column (150 mm × 4.6 mm; 5 μm) using isocratic elution with the mobile phase containing 40 mM of potassium phosphate monobasic (pH 3.0) and acetonitrile (56:44), at a flow rate of 0.7 mL/min. The optimized method was validated and met the requirements of the International Conference on Harmonization. The developed method was applied to determine loperamide hydrochloride in capsules and can be used to update the current monograph in KP XII.

    keywords
    loperamide hydrochloride, capsules, assay, DoE, HPLC


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