Research Article
Year 2023,
Volume: 2 Issue: 2, 53 - 58, 28.08.2023
Abstract
Project Number
2005S039
References
- Scott LJJD. Selexipag: first global approval. Drugs. 2016;76:413-8. https://doi.org/10.1007/s40265-016-0549-4
- Richter MJ, Gall H, Grimminger J, Grimminger F, Ghofrani H-A. Selexipag for the treatment of pulmonary arterial hypertension. Expert Opin Pharmacother. 2016;17(13):1825-34. https://doi.org/10.1080/14656566.2016.1215429
- Xie S, Shi L, Chen J, Xu R-a, Ye X, Analysis B. Simultaneous quantification and pharmacokinetic investigation of selexipag and its main metabolite ACT-333679 in rat plasma by UPLC-MS/MS method. J Pharm Biomed Anal. 2020;190:113496. https://doi.org/10.1016/j.jpba.2020.113496
- Gumustas M, Kurbanoglu S, Uslu B, Ozkan SA. UPLC versus HPLC on drug analysis: advantageous, applications and their validation parameters. J Chromatographia. 2013;76:1365-427. https://doi.org/10.1007/s10337-013-2477-8
- Damireddy S, Pravalika K, Praveen M, Sathish G, Anusha M. Method development and validation of selexipag in its bulk and dosage form by rp-HPLC. J Int J Pharm Biol Sci. 2017;7:84. ISSN: 2230-7605
- Youssef YM, Mahrouse MA, Mostafa E. Assessment of environmental impact of a novel stability-indicating RP-HPLC method and reported methods for the determination of selexipag in bulk and dosage form: A comparative study using different greenness assessment tools. Microchem J. 2023;185:108256. https://doi.org/10.1016/j.microc.2022.108256
- Amara Babu NL, Koganti K, Palakeeti B, Srinivas KS, Rao KP. Development of an efficient stability-indicating LC–MS/MS method for the analysis of selexipag and characterization of its degradation products. Biomed. Chromatogr. 2021;35(10):e5178.
- Bhadru B, Rao VV, Vidhyadhara S, Research. Development and validation of bioanalytical method for the quantitative estimation of selexipag in biological matrices using LC-MS/MS. J Pharm Sci. 2019;11(7):2722-7. ISSN:0975-1459
- Gorumutchu GP, Ratnakaram NR. Oxidative coupling: A tranquil approach for determination of selexipag by visible spectrophotometry. Orient. J. Chem. 2018;34(6):3112. http://dx.doi.org/10.13005/ojc/340656
- Ceylan B, Tırıs G, Tekkeli SEK, Önal C, Önal A. A novel HPLC method for selexipag in human plasma and application to a pharmacokinetic study. Research Square. 2022. https://doi.org/10.21203/rs.3.rs-1877128/v1
- Prathyusha SM, Deepti CA, Naik RR, Technology. Development and validated of spectrophotometric methods for the determination of Selexipag (An anti-hypertensive agent). RJPT. 2020;13(3):1346-50. https://doi.org/10.5958/0974-360X.2020.00248.6
Year 2023,
Volume: 2 Issue: 2, 53 - 58, 28.08.2023
Abstract
Selexipag is a new non-prostanoid prostacyclin receptor agonist used to treat pulmonary arterial hypertension. Selexipag is a long-acting IP receptor agonist with a shorter half-life than all other licensed drugs targeting the prostacyclin pathway, mostly administered intravenously or by subcutaneous infusion or inhalation. In this study, a new high performance liquid chromatography (HPLC) method was developed to analyze Selexipag in bulk and pharmaceutical formulations. The method used a column with Supelco Ascentis® Express (Sigma Aldrich, USA) model phenyl hexyl functional group (100×4.6 mm, ID, 2.7µm). Chromatographic separation was in isocratic elution mode, and the mobile phase mixture was acetonitrile containing 0.1% formic acid: water containing 0.1% formic acid (60:40, v/v) ratio. The method was linear in the concentration range of 15.7-117.6 µg/mL, and the LOD and LOQ were obtained as 2.4 and 3.1 µg/mL, respectively. Various method parameters have been tested according to the ICH Q2(R1) manual, and it is a method with high accuracy and precision. Therefore, the developed method is suitable for selexipag’s bulk and pharmaceutical formulation analysis.
Keywords
Supporting Institution
Anadolu University Scientific Research Projects Fund Commission
Project Number
2005S039
References
- Scott LJJD. Selexipag: first global approval. Drugs. 2016;76:413-8. https://doi.org/10.1007/s40265-016-0549-4
- Richter MJ, Gall H, Grimminger J, Grimminger F, Ghofrani H-A. Selexipag for the treatment of pulmonary arterial hypertension. Expert Opin Pharmacother. 2016;17(13):1825-34. https://doi.org/10.1080/14656566.2016.1215429
- Xie S, Shi L, Chen J, Xu R-a, Ye X, Analysis B. Simultaneous quantification and pharmacokinetic investigation of selexipag and its main metabolite ACT-333679 in rat plasma by UPLC-MS/MS method. J Pharm Biomed Anal. 2020;190:113496. https://doi.org/10.1016/j.jpba.2020.113496
- Gumustas M, Kurbanoglu S, Uslu B, Ozkan SA. UPLC versus HPLC on drug analysis: advantageous, applications and their validation parameters. J Chromatographia. 2013;76:1365-427. https://doi.org/10.1007/s10337-013-2477-8
- Damireddy S, Pravalika K, Praveen M, Sathish G, Anusha M. Method development and validation of selexipag in its bulk and dosage form by rp-HPLC. J Int J Pharm Biol Sci. 2017;7:84. ISSN: 2230-7605
- Youssef YM, Mahrouse MA, Mostafa E. Assessment of environmental impact of a novel stability-indicating RP-HPLC method and reported methods for the determination of selexipag in bulk and dosage form: A comparative study using different greenness assessment tools. Microchem J. 2023;185:108256. https://doi.org/10.1016/j.microc.2022.108256
- Amara Babu NL, Koganti K, Palakeeti B, Srinivas KS, Rao KP. Development of an efficient stability-indicating LC–MS/MS method for the analysis of selexipag and characterization of its degradation products. Biomed. Chromatogr. 2021;35(10):e5178.
- Bhadru B, Rao VV, Vidhyadhara S, Research. Development and validation of bioanalytical method for the quantitative estimation of selexipag in biological matrices using LC-MS/MS. J Pharm Sci. 2019;11(7):2722-7. ISSN:0975-1459
- Gorumutchu GP, Ratnakaram NR. Oxidative coupling: A tranquil approach for determination of selexipag by visible spectrophotometry. Orient. J. Chem. 2018;34(6):3112. http://dx.doi.org/10.13005/ojc/340656
- Ceylan B, Tırıs G, Tekkeli SEK, Önal C, Önal A. A novel HPLC method for selexipag in human plasma and application to a pharmacokinetic study. Research Square. 2022. https://doi.org/10.21203/rs.3.rs-1877128/v1
- Prathyusha SM, Deepti CA, Naik RR, Technology. Development and validated of spectrophotometric methods for the determination of Selexipag (An anti-hypertensive agent). RJPT. 2020;13(3):1346-50. https://doi.org/10.5958/0974-360X.2020.00248.6
There are 11 citations in total.
Details
| Primary Language | English |
|---|---|
| Subjects | Pharmacology and Pharmaceutical Sciences (Other) |
| Journal Section | Research Articles |
| Authors | |
| Project Number | 2005S039 |
| Publication Date | August 28, 2023 |
| Submission Date | June 27, 2023 |
| Published in Issue | Year 2023 Volume: 2 Issue: 2 |
