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Published on:August 2019
Indian Journal of Pharmaceutical Education and Research, 2019; 53(3s):s364-s372
Original Article | doi:10.5530/ijper.53.3s.107

Simultaneous Determination of Canagliflozin and Metformin in Human Plasma by LC–MS/MS Assay and its Application to a Human Pharmacokinetic Study


Authors and affiliation (s):

Muralikrishna Ramisetti1, Lakshmana Rao Atmakuri2,*, Basaveswara Rao Mandava Venkata3, Vinayender Adireddy4

1Faculty of Pharmacy, Krishna University, Machilipatnam, Andhra Pradesh, INDIA.

2V. V. Institute of Pharmaceutical Sciences, Gudlavalleru, Andhra Pradesh, INDIA.

3Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, INDIA.

4PCR Laboratories, Ramanthapur, Hyderabad, Telangana, INDIA.

Abstract:

Objective: The main objective of this work was to develop a simple, rapid and sensitive liquid chromatography/tandem mass spectrometry (LC–MS/MS) method for the simultaneous quantification of Canagliflozin and Metformin. Methods: Deuterated compounds of respective drugs were used an internal standard. Sample extraction was carried out using a simple Protein Precipitation (PP) technique. A C18 column with an isocratic mobile phase composed of 5mM ammonium acetate with 0.01% formic acid and methanol were used for chromatographic separation. Results: The method was validated in the linearity range of 10.00–6028.00 ng/mL for Canagliflozin and 10.00– 3027.00 ng/mL for Metformin. The precision and accuracy results over five concentration levels in five different batches were well within the acceptance limits. A variety of stability tests were executed in plasma and in neat samples are comply with the FDA guidelines. Conclusion: The proposed assay method is simple, rapid and sensitive for the simultaneous determination of Canagliflozin and Metformin in human plasma. This method was successfully used to quantitate the in vivo plasma concentrations obtained from a pharmacokinetic study.

Key words: Canagliflozin, Metformin, Human Plasma, LC–MS/MS, Method Validation, Pharmacokinetics.

 

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IJPER - An Official Publication of Association of Pharmaceutical Teachers of India is pleased to announce continued growth in the 2019 Release of Journal Citation Reports (source: 2018 Web of Science Data).

 

Impact Factor® as reported in the 2018 Journal Citation Reports® (Clarivate Analytics, 2019): 0.425

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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