Development and Validation of Stability Indicating LC Method for Selexipag: In-Silico Toxicity Study and Characterization of its Degradation Products
نویسندگان
1 Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Adgaon, Nashik 422003, India
2 Department of Quality Assurance, MET’s Institute of Pharmacy, Adgaon, Nashik 422003, India
3 Department of Pharmaceutics, KBHSS Trust's Institute of Pharmacy, Malegaon, Nashik, Maharashtra 423105, India
4 Department of Pharmaceutical Chemistry, KBHSS Trust's Institute of Pharmacy, Malegaon, Nashik, Maharashtra 423105, India
5 Department of Pharmaceutical Sciences, Ibn Sina National College for Medical Studies, Jeddah, Saudi Arabia
6 Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Adgaon, Nashik 422003, India
7 Department of Pharmaceutical Analysis, Care College of Pharmacy, Oglapur, Warangal, Telangana, India
8 Department of Pharmaceutical Chemistry, N.B.S Institute of Pharmacy, Ausa, latur, Maharashtra, India
doi
10.48309/chemm.2025.507044.1903چکیده
An RP-HPLC method for quantifying selexipag in bulk and tablet formulations was developed and validated, and was found to be fast, sensitive, precise, accurate, and stable. Isocratic separation of Selexipag (SLG) was carried out using a Kromasil C18 column (150 mm×4.6 mm, 5μm) with a mobile phase that included 80:20% v/v of acetonitrile and phosphate buffer (pH 3.0) at a flow rate of 1.0 mL/min. The column was maintained at 30 ± 2 °C and the wavelength for detection was set to 270 nm. The SLG peak was detected at 3.380 minutes. The proposed method was linear within the 05-25 μg/mL range, with both drugs having a correlation value of 0.999. For DL, it was 0.633 μg/mL and for QL, it was 1.920 μg/mL. Although oxidative and photolytic degradation were able to stabilize SLG, acidic, alkaline, and humid heat conditions caused it to disintegrate. Liquid chromatography-mass spectrometry (LC-MS) analysis was used to verify the degradation products. The m/z of the moist heat degradation product was 454.54, while the alkali degradation product had an m/z of 419.51. Even when degradation products were present, the RP-HPLC measurements of SLG were sensitive, accurate, and exact, suggesting that the substance was stable. During the examination of SLG, it was determined that it degrades under acidic, alkaline, and moist heat conditions, whereas it is stable under oxidative and photolytic conditions. LC-MS analysis was performed to confirm the presence of degradation products.
