Determination of beraprost in human plasma by a high-performance liquid chromatography–tandem mass spectrometry

Lee, J.; Kim, H.; Jeong, Jee‐Yeong; Park, E.S.; Hwang, Kwang Woo; Yang, Sehee; Jeong, Ji Hoon

doi:10.1016/j.jchromb.2007.09.034

Cited by 4 publications

(2 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…PK studies of BPS immediate‐release tablets have been conducted in Japan [ 26 ], Europe [ 27 ], and South Korea [ 28 ] and have not shown significant differences in any PK parameters. Similar results were noted for TRK‐100STP in a study comparing PK among Japanese, Chinese, and Koreans (unpublished data).…”

Section: Discussionmentioning

confidence: 99%

Prostacyclin analog beraprost sodium efficacy in primary glomerular disease or nephrosclerosis: Analysis of the Japanese subgroup in CASSIOPEIR study

et al. 2021

View full text Add to dashboard Cite

We conducted a multicenter, randomized, double-blind, placebo-controlled, phase IIb/III study (CASSIOPEIR) using a renal composite endpoint (i.e., doubling of SCr or end-stage renal disease) in seven Asian countries/region. CASSIOPEIR compared TRK-100STP (120 μg and 240 μg) with placebo in patients with non-diabetic CKD patients with primary glomerular disease or nephrosclerosis (n = 892). However, the superiority of TRK-100STP over placebo was not observed. A prior phase II study on which the Phase IIb/III study design was based included only Japanese patients. We therefore evaluated TRK-100STP efficacy and safety in a subgroup of Japanese patients using the CASSIOPEIR dataset. As the timing of treatment initiation is important in CKD, we conducted additional subgroup analyses based on the baseline serum creatinine (SCr) and eGFR. ITT analysis was performed in a Japanese subgroup (n = 339) in which the primary endpoint was the first occurrence of renal composite endpoint. Significant differences were observed for TRK-100STP 240 μg vs. placebo (P = 0.0493; HR 0.69 [95% CI: 0.47, 1.00]), but no significant difference was observed between TRK-100 120 μg and placebo (P = 0.3523; HR 0.85). More prominent improvement was observed with TRK-100STP 240 μg vs. placebo for baseline SCr < 3.0 mg/dL (P = 0.0031; HR 0.43); SCr < 3.5 mg/dL (P = 0.0237, HR 0.59); and eGFR ≥ 10 mL/min/1.73 m 2 (P = 0.0339, HR0.67), respectively.No significant changes in urinary albumin/creatinine ratio and blood pressure were observed. TRK-100STP was generally well tolerated and most adverse drug reactions were mild or moderate in severity. In conclusion, in the Japanese subgroup of CASSIOPEIR, TRK-100STP 240 μg/day significantly improved the renal composite endpoint compared with placebo, with greater efficacy in subjects with SCr < 3.5 or eGFR ≥ 10 mL/min/1.73 m 2 .

show abstract

Section: Discussionmentioning

confidence: 99%

Prostacyclin analog beraprost sodium efficacy in primary glomerular disease or nephrosclerosis: Analysis of the Japanese subgroup in CASSIOPEIR study

et al. 2021

View full text Add to dashboard Cite

show abstract

“…Radioimmunoassay has been successfully used to determine beraprost in human plasma, but this method required specially trained personnel and involved radiation hazard (Demolis et al, 1993). The LC-MS/MS method has also been developed with limits of quantitation (LOQ) of 20 and 25 pg/mL (Chen, Way, Peng, et al, 2008;Lee et al, 2007). This paper presents an LC-MS/MS method which is more sensitive using simple liquid-liquid extraction.…”

Section: Introductionmentioning

confidence: 99%

Study on bioequivalence of beraprost in healthy volunteers by liquid chromatography with tandem mass spectrometry

Prasaja¹,

Harahap

Lusthom³

et al. 2018

Biomedical Chromatography

View full text Add to dashboard Cite

Beraprost sodium is an oral prostacyclin analog that was first approved in 1992 (Japan) for the treatment of peripheral vascular disorders. It is administered orally as a tablet available in strength 20 μg. In this paper, we described a liquid chromatography tandem mass spectrometry method that was developed for the quantification of beraprost in human plasma with high sensitivity at picogram per milliliter concentration. The method had been validated in terms of selectivity, sensitivity, accuracy and precision, matrix effect, linearity, recovery and carry-over according to the Guideline on Bioanalytical Validation from the European Medicines Agency. The standard calibration curve for beraprost was 9.5-1419 pg/mL. This method has been applied successfully to a bioequivalence study with 60 μg of beraprost (three tablets) in 29 healthy volunteers.The results showed that the two formulations of beraprost are bioequivalent.

show abstract

Current literature in mass spectrometry

2008

J. Mass Spectrom.

View full text Add to dashboard Cite

INSTRUMENTAL TECHNIQUES & METHODSAguilera JOURNAL OF MASS SPECTROMETRY J. Mass Spectrom. 2008; 43: 1009-1020 Published online in Wiley InterScience (www.interscience.wiley.com). DOI:10.1002DOI:10. /jms.1304 Current literature in mass spectrometry (4 weeks journals -Search completed at 23rd. Apr. 2008) In order to keep subscribers up-to-date with the latest developments in their field, John Wiley & Sons are providing a current awareness service in each issue of the journal. The bibliography contains newly published material in the field of mass spectrometry. Each bibliography is divided into 11 sections: 1 Reviews; 2 Instrumental Techniques & Methods; 3 Gas Phase Ion Chemistry; 4 Biology/Biochemistry: Amino Acids, Peptides & Proteins; Carbohydrates; Lipids; Nucleic Acids; 5 Pharmacology/Toxicology; 6 Natural Products; 7 Analysis of Organic Compounds; 8 Analysis of Inorganics/Organometallics; 9 Surface Analysis; 10 Environmental Analysis; 11 Elemental Analysis. Within each section, articles are listed in alphabetical order with respect to author. GAS PHASE ION CHEMISTRY

show abstract

Determination of beraprost in human plasma by a high-performance liquid chromatography–tandem mass spectrometry

Cited by 4 publications

References 11 publications

Prostacyclin analog beraprost sodium efficacy in primary glomerular disease or nephrosclerosis: Analysis of the Japanese subgroup in CASSIOPEIR study

Prostacyclin analog beraprost sodium efficacy in primary glomerular disease or nephrosclerosis: Analysis of the Japanese subgroup in CASSIOPEIR study

Study on bioequivalence of beraprost in healthy volunteers by liquid chromatography with tandem mass spectrometry

Current literature in mass spectrometry

Contact Info

Product

Resources

About