Jawa Ghazanfar Ali1, Islam Muhammad1, Saeed Hamid1, Muhammad Ali A2, Hakeem Shoaib2 and Samiyah Tasleem3*
1Department of Microbiology, University of the Punjab, Pakistan
2Department of Microbiology, Wilshire Laboratory, Pakistan
3Department of Microbiology, University of Karachi, Pakistan
The paper describes the development of novel and robust HPLC method for the determination and quantification of Paracetamol, Caffeine, and Orphenadrine Citrate in a solid dosage form. The chromatographic separation was achieved with RP C18 column Merck (5 μm, 4.6 mm × 250 mm) using buffer and methanol (680:320 v/v) as a mobile phase. The flow rate was set at 1.0 ml/min with column oven temperature maintained at 50°C. The method validation was performed as per ICH guidelines. The results of the validation showed satisfactory results and complied with the acceptance criteria. The Correlation coefficient (R2) was greater than 0.999 for all three components. The retention time was found to be 3 min ± 0.5 min (Paracetamol), 5.6 ± 0.02 min (Caffeine), 33 ± 1 min (Orphenadrine Citrate) respectively. The limit of detection for Paracetamol, Caffeine, and Orphenadrine Citrate was 2.8091, 2.837, and 1.3408 respectively. Stress degradation studies were performed by subjecting the analytes to various stress conditions, acidic and alkaline hydrolysis, photolytic degradation, Thermal degradation. The samples proved to be stable under all conditions
except photolytic degradation. The method developed effectively separates the analytes from the degradation products if any without much variation in their retention time. Finally, the method developed proved to be suitable for the routine analysis of Paracetamol, Caffeine and Orphenadrine Citrate under isocratic conditions.
Stability indicating HPLC; Paracetamol; Caffeine; Orphenadrine citrate; Solid dosage form
Ali JG, Muhammad I, Hamid S, Muhammad Ali A, Shoaib H, Tasleem S. Simultaneous Determination and Quantification of Paracetamol, Caffeine and Orphenadrine Citrate using Stability Indicating HPLC Method in a Fixed-Dose Combination Tablet Dosage Form. Ann Pharmacol Pharm. 2020;5(3):1185.