HIGH – PERFORMANCE LIQUID CHROMATOGRAPHY METHOD VALIDATION AND DEVELOPMENT STRATEGY FOR RIFABUTINAbstract
A simple, economical, accurate and precise high performance liquid chromatographic method was developed and validated for the determination of rifabutin. A Shimadzu LC-2010C HT version 3.01 system using a C-18 column with dimensions of 250 × 4.6 mm and silica particle size of 5 μm. Isocratic elution was employed with methanol, acetonitrile and water (75:25 v/v) were used. The flow rate was 1 ml/min, and effluents were monitored at 242 nm. The HPLC method was extensively validated for linearity, accuracy, precision (Interday precision, Intraday precision), repeatability and robustness. The exalted results receive of a drug were procured all significance values were established to be under the acceptable range in International Conference of Harmonization (ICH) guidelines requirements. The results demonstrate that the developed HPLC modus could be successfully used up for identification and quantification of Rifabutin in any form of the drug, with high resolution, accuracy, and precision.
G. Singh * and A. K. Srivastava
Department of Pharmaceutical Engineering and Technology, Indian Institute of Technology, (Banaras Hindu University) Varanasi, Uttar Pradesh, India.
20 December, 2017
20 February, 2018
26 June, 2018
01 September, 2018