A novel, sensitive and selective method of UPLC/MS–MS for rapid simultaneous determination of midodrine and its active metabolite desglymidodrine in human plasma: Application to support bioequivalence study in healthy human volunteers
Abstract
A specific, rapid, sensitive and selective ultra-performance liquid chromatography - tandem mass spectrometry has been developed for the simultaneous determination of midodrine and desglymidodrine in human plasma. The analytes and its deuterated analogs were quantitatively extracted from 100μL of human plasma by solid phase extraction technique. Separation of analytes was achieved on the Waters Acquity UPLC BEH C18 (50×2.1mm, 1.7μm) column using acetonitrile-4.0mM ammonium formate, pH 2.5(90:10, v/v) as mobile phase. The protonated analytes were quantified by selected reaction monitoring in the positive ionization mode by triple quadrupole mass spectrometer. The calibration plots were linear over the concentration range of 0.050-50.0ng/mL. The intra-batch and inter-batch precision (%CV) across quality control levels was <4.0 and the% mean relative recovery was ≥96%. Various other parameters like stability in different conditions; matrix effect and reproducibility of the method were performed in accordance with the guidelines specified by the USFDA for bioanalytical method development and validation. The developed method was successfully administered to the pharmacokinetics study of 5 mg midodrine tablet in 12 healthy subjects. Reproducibility of assay was proved by reanalysis of 48 incurred samples.
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Midodrine time to peak concentration is 1 h after administration, and pharmacologic effects last 4-5 h.
“Time to peak concentration is 1 h after administration, and pharmacologic effects last 4-5 h (55).”
From Postural orthostatic tachycardia syndrome: mechanisms and new therapies (2020) · cites this paper as [55]
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Postural orthostatic tachycardia syndrome: mechanisms and new therapies
Mar, P. L., & Raj, S. R. (2020) · Annual Review of Medicine · doi:10.1146/annurev-med-041818-011630 · Cited by 122 · see citing works
- Authors
- Patel, D. P., Nair, S., Suhagia, B. N., & Patel, B. M.
- Affiliations
- National Cancer Institute (US)
- Gujarat University (IN)
- Dharmsinh Desai University (IN)
- St Xavier’s College (IN)
- Corresponding author
- Patel, Bhargav M.
- Venue
- Journal of Pharmaceutical and Biomedical Analysis
- Publisher
- Elsevier BV
- Published
- 2016-11
- Volume
- 131
- Pages
- 355-363
- ISSN
- 0731-7085 (ISSN-L)
- OpenAlex
- W2515460764
- Cited by
- 15
- References
- 16
- Citations by year
- 2025: 2 · 2024: 3 · 2023: 3 · 2022: 1 · 2019: 3 · 2018: 2 · 2017: 1
- FWCI
- 1.58
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Pharmaceutical and Biomedical Analysis (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Forensic Toxicology and Drug Analysis
- Keywords
- midodrine, UPLC-MS/MS, human plasma, bioequivalence, pharmacokinetics, solid-phase extraction, deuterated internal standards, bioanalytical method validation, healthy volunteers
- MeSH terms
- Chromatography, High Pressure Liquid, Humans, Midodrine, Therapeutic Equivalency, Time Factors, Cross-Over Studies, Tandem Mass Spectrometry
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