Stability indicating LC-MS/MS method and validation of Selexipag impurities and identification of its force degradation products
Selexipag belongs to a class of medicines known as IP prostacyclin receptor agonists used to treat pulmonary arterial hypertension. A simple and sensitive LC-MS/MS method has been developed for the identification of process related impurities in Selexipag API. The method was developed using a Zorbax...
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-12-01
|
| Series: | Results in Chemistry |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2211715623002618 |
| _version_ | 1797398648157372416 |
|---|---|
| author | Pranavkumar Shah Sanjay Hadiyal Bhavin Dhaduk |
| author_facet | Pranavkumar Shah Sanjay Hadiyal Bhavin Dhaduk |
| author_sort | Pranavkumar Shah |
| collection | DOAJ |
| description | Selexipag belongs to a class of medicines known as IP prostacyclin receptor agonists used to treat pulmonary arterial hypertension. A simple and sensitive LC-MS/MS method has been developed for the identification of process related impurities in Selexipag API. The method was developed using a Zorbax C18 15 × 0.46 cm, 5μ column with a gradient program at 35 0C and flow rate of 1.0 mL/min. Detection was carried out by MS/MS with an ESI detector. Stress conditions were established by exposing the drug to acidic, alkaline, oxidative, thermal and photolytic stress condition. Identified and unidentified impurity was found when the fractions of acid and alkaline degradation product was analyzed by LC-MS/MS. The suggested methodology can be used to test the quality of Selexipag and identify the process-related impurities in pharmaceutical products. |
| first_indexed | 2024-03-09T01:28:36Z |
| format | Article |
| id | doaj.art-b9d4c4857fff4d4eaff1f9757271ff10 |
| institution | Directory Open Access Journal |
| issn | 2211-7156 |
| language | English |
| last_indexed | 2024-03-09T01:28:36Z |
| publishDate | 2023-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Results in Chemistry |
| spelling | doaj.art-b9d4c4857fff4d4eaff1f9757271ff102023-12-10T06:14:56ZengElsevierResults in Chemistry2211-71562023-12-016101022Stability indicating LC-MS/MS method and validation of Selexipag impurities and identification of its force degradation productsPranavkumar Shah0Sanjay Hadiyal1Bhavin Dhaduk2Department of Chemistry, School of Science, RK University, Rajkot-360 020, Gujarat, IndiaDepartment of Chemistry, Faculty of Science, Atmiya University, Rajkot-360 005, Gujarat, IndiaDepartment of Chemistry, School of Science, RK University, Rajkot-360 020, Gujarat, India; Department of Chemistry, Faculty of Science, Atmiya University, Rajkot-360 005, Gujarat, India; Corresponding author.Selexipag belongs to a class of medicines known as IP prostacyclin receptor agonists used to treat pulmonary arterial hypertension. A simple and sensitive LC-MS/MS method has been developed for the identification of process related impurities in Selexipag API. The method was developed using a Zorbax C18 15 × 0.46 cm, 5μ column with a gradient program at 35 0C and flow rate of 1.0 mL/min. Detection was carried out by MS/MS with an ESI detector. Stress conditions were established by exposing the drug to acidic, alkaline, oxidative, thermal and photolytic stress condition. Identified and unidentified impurity was found when the fractions of acid and alkaline degradation product was analyzed by LC-MS/MS. The suggested methodology can be used to test the quality of Selexipag and identify the process-related impurities in pharmaceutical products.http://www.sciencedirect.com/science/article/pii/S2211715623002618SelexipagPulmonary arterial hypertension (PHA)Related impuritiesLC-MS/MS |
| spellingShingle | Pranavkumar Shah Sanjay Hadiyal Bhavin Dhaduk Stability indicating LC-MS/MS method and validation of Selexipag impurities and identification of its force degradation products Results in Chemistry Selexipag Pulmonary arterial hypertension (PHA) Related impurities LC-MS/MS |
| title | Stability indicating LC-MS/MS method and validation of Selexipag impurities and identification of its force degradation products |
| title_full | Stability indicating LC-MS/MS method and validation of Selexipag impurities and identification of its force degradation products |
| title_fullStr | Stability indicating LC-MS/MS method and validation of Selexipag impurities and identification of its force degradation products |
| title_full_unstemmed | Stability indicating LC-MS/MS method and validation of Selexipag impurities and identification of its force degradation products |
| title_short | Stability indicating LC-MS/MS method and validation of Selexipag impurities and identification of its force degradation products |
| title_sort | stability indicating lc ms ms method and validation of selexipag impurities and identification of its force degradation products |
| topic | Selexipag Pulmonary arterial hypertension (PHA) Related impurities LC-MS/MS |
| url | http://www.sciencedirect.com/science/article/pii/S2211715623002618 |
| work_keys_str_mv | AT pranavkumarshah stabilityindicatinglcmsmsmethodandvalidationofselexipagimpuritiesandidentificationofitsforcedegradationproducts AT sanjayhadiyal stabilityindicatinglcmsmsmethodandvalidationofselexipagimpuritiesandidentificationofitsforcedegradationproducts AT bhavindhaduk stabilityindicatinglcmsmsmethodandvalidationofselexipagimpuritiesandidentificationofitsforcedegradationproducts |