Abstract

The present application wish to seem at the event of validation of bio analytical method and pharmacokinetic study of selexipag and its related impurities in rat plasma using LC–MS/MS. The optimized method contains gradient elution of selexipag with a flow rate of 1 ml/min and X-Bridge phenyl column (150 × 4.6 mm, 3.5 µ). A buffer of 1 mL formic acid in l liter water and acetonitrile mixture is used as mobile phase. 30 min run time was used for separation of selexipag and its related impurities with Ambrisentan as internal standard and impurity-D as active metabolite. The linearity curves are linear in between the percentages of 10 to 200% of rat plasma and R2 value of each analyte was observed as 0.999. This application denotes all the parameters like precision, accuracy, recovery and stability were got the results within the limit of USFDA guidelines. This method applies effectively for the investigation of pharmacokinetic studies using rat plasma.

Highlights

  • Selexipag is obtained from Actelion [1] is employed pulmonary arterial hypertension (PAH) [2, 3] to slow down disease development and decrease the possibility of hospitalization

  • Europe country selexipag used as strong inhibitors in liver enzyme in gemfibrozil [10, 11] is contraindicated because it increases concentrations of selexipag two fold and its working metabolite 11 fold, potentially resulting in more adverse effects

  • The adverse effects of selexipag are almost like those of intravenous prostacyclin[12] used for pulmonary arterial hypertension

Read more

Summary

Introduction

Selexipag is obtained from Actelion [1] is employed pulmonary arterial hypertension (PAH) [2, 3] to slow down disease development and decrease the possibility of hospitalization. Selexipag and its active metabolite are agonists [4, 5] of the professional stacycline receptor, which results in vasodilation [6] within the circulation [7, 8] and reduce elevated pressure within the blood cells carrying blood to the lungs. Europe country selexipag used as strong inhibitors in liver enzyme in gemfibrozil [10, 11] is contraindicated because it increases concentrations of selexipag two fold and its working metabolite 11 fold, potentially resulting in more adverse effects. The adverse effects of selexipag are almost like those of intravenous prostacyclin[12] used for pulmonary arterial hypertension. It is deals with organictestscarrying the substance alongside a various

HPLC conditions
Chemicals and reagents
Equipment
Preparation of standard and quality control samples
Preparation of sample solution
Precision and accuracy
Recovery
Stability
Results and discussion
Selectivity and sensitivity
Linearity
Prediction linearity
Re‐injection and reproducibility
3.1.10 Pharmacokinetic study
Compliance with ethical standards
Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call