| Autor: |
Abdelrahman MM; Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., 62514 Beni-Suef, Egypt., Naguib IA; Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., 62514 Beni-Suef, Egypt., El Ghobashy MR; Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., 11562 Cairo, Egypt., Ali NA; Medicolegal Authority, Justice Ministry, 114 Bairam El Tounsy St., El Sayeda Zeinab, 11647 Cairo, Egypt. |
| Abstrakt: |
Two accurate, sensitive and highly selective stability-indicating methods are developed and validated for simultaneous determination of Agomelatine (AGM) and its forced degradation products (Deg I and II). The first method is High-Performance Liquid Chromatography for separation and quantitation of AGM, Deg I and II on a C18 column (250 mm × 4.6 mm, 5 μm p.s) in isocratic mode by using a binary mixture of Potassium dihydrogen phosphate (0.05 M, pH adjusted to 2.9 with orthophosphoric acid): acetonitrile (60:40, v/v) at a flow rate of 2 mL/min. The components were detected at 230 nm over a concentration range of 0.5-10 μg/mL for AGM and 0.5-5 μg/mL for both Deg I and II. The second method is High-Performance Thin-Layer Chromatography, where AGM, Deg I and II were separated on silica gel HPTLC F254 plates using chloroform:methanol:ammonia solution (9:1:0.1, by volume) as a developing system. The separated bands were scanned at 230 nm over the concentration range of 0.2-1.2 μg/band for AGM in pure form and human plasma and 0.1-1 μg/band for both Deg I and II. The proposed methods were successfully applied for analysis of AGM in pharmaceutical formulations. The results obtained by the proposed methods were statistically compared to the reported HPLC method revealing high accuracy and good precision. |
