Author:
Rao T. N,Prasanthi Y.,Botsa Parvatamma,Kumara G.,Rao K. A.,
Abstract
A simple and inexpensive method was developed using high performance liquid chromatography with PDA detection for determination of granisetron hydrochloride and related impurities (2-methyl-N- [(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-2H-indazole-3-carboxamide, 1-Methyl-N-[(1R,3r,5S)- 9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide hydrochloride, N-[(1R,3r,5S)-9- azabicyclo[3.3.1]non-3-yl]-1-methyl-1H-indazole-3-carboxamide and 1-methyl-1H-indazole-3-carboxylic acid. The chromatographic separations were achieved on (250×4.6 mm), 5.0 μm make: Waters, Symmetry Shield C8 column employing acetonitrile: 2% V/V H3PO4 in MilliQ water + 0.1% V/V hexylamine in water, 800:200 V/V (pH adjusted to 7.5 using triethylamine) mobile phase with isocratic programme. A flow rate of 1.5 mL/min was chosen. Four impurities were eluted within 20 minutes. The column temperature was maintained at 40°C and a detector wavelength of 300 nm was employed. The method was successfully validated by establishing system suitability, specificity, linearity, accuracy, limit of detection and limit of quantification.
Publisher
Indian Drug Manufacturers' Association (IDMA)
Subject
Drug Discovery,Pharmaceutical Science,Pharmacology