Method Development and Validation for Estimation of Istradefylline in Tablet Dosage form by RP-HPLC

Autor: Nagarjuna Hari Pratap S, Krishna Kishore Adireddy, Srinivasa Rao Baratam
Rok vydání: 2021
Předmět:
Zdroj: Research Journal of Pharmacy and Technology. :4767-4772
ISSN: 0974-360X
0974-3618
Popis: A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of Istradefylline in table dosage form. Chromatographic analysis of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. C18G column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of 0.1 % orthophosphoric acid and acetonitrile in the ratio of 30: 70 v/v. The method showed a good linear response in the concentration range of 10-90 μg/ml with correlation coefficient of 0.9993. The flow rate was maintained at 1.0 ml/min and detection was carried out at 246 nm. The retention time was 3.125 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of istradefylline in tablet formulation.
Databáze: OpenAIRE