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Research Article

Simultaneous determination of duloxetine and 4-hydroxy duloxetine glucuronide in human plasma and back-conversion study

    Gabriel Onn Kit Loh

    Bioxis Sdn. Bhd. PMT 1241, Jalan Perindustrian Bukit Minyak 8, Taman Perindustrian Bukit Minyak, Simpang Ampat, 14100, Penang, Malaysia

    ,
    Emily Yii Ling Wong

    Bioxis Sdn. Bhd. PMT 1241, Jalan Perindustrian Bukit Minyak 8, Taman Perindustrian Bukit Minyak, Simpang Ampat, 14100, Penang, Malaysia

    ,
    Yvonne Tze Fung Tan

    Bioxis Sdn. Bhd. PMT 1241, Jalan Perindustrian Bukit Minyak 8, Taman Perindustrian Bukit Minyak, Simpang Ampat, 14100, Penang, Malaysia

    ,
    Yi Lin Lee

    Centre for Clinical Trial, Institute for Clinical Research, Ampang Hospital, Ministry of Health, Jalan Mewah Utara, Pandan Mewah, Ampang, 68000, Selangor, Malaysia

    ,
    Chun Keat Chew

    Centre for Clinical Trial, Institute for Clinical Research, Ampang Hospital, Ministry of Health, Jalan Mewah Utara, Pandan Mewah, Ampang, 68000, Selangor, Malaysia

    ,
    Nurul Diyana Mohd Sali

    Centre for Clinical Trial, Institute for Clinical Research, Ampang Hospital, Ministry of Health, Jalan Mewah Utara, Pandan Mewah, Ampang, 68000, Selangor, Malaysia

    ,
    Damenthi Nair

    Centre for Clinical Trial, Institute for Clinical Research, Ampang Hospital, Ministry of Health, Jalan Mewah Utara, Pandan Mewah, Ampang, 68000, Selangor, Malaysia

    &
    Kok Khiang Peh

    *Author for correspondence: Tel.: +604 653 2257;

    E-mail Address: kkpeh@usm.my

    School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, 11800, Penang, Malaysia

    Published Online:https://doi.org/10.4155/bio-2021-0185

    Aim: To develop an LC-MS/MS method for simultaneous determination of duloxetine and its metabolite, 4-hydroxy duloxetine glucuronide (4HDG) in human plasma and to investigate the potential back-conversion of 4HDG to duloxetine using stability study. Materials & methods: The LC-MS/MS method was validated according to the EMA and USFDA Bioanalytical Method Validation Guidelines and applied to pilot bioequivalence study. Results & conclusion: The method validation results were within the acceptance limits. The stability study and incurred sample reanalysis results ruled out the occurrence of back-conversion. The study highlighted the conduct of back-conversion test and the advantages of LC-MS/MS method in terms of sensitivity, specificity and low consumption of organic solvents.

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

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