DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF ARGATROBAN IN BULK AND IN PHARMACEUTICAL DOSAGE FORM
Varsha Rajkumar Jamakhandi, Dr. M.S. Kalshetti, Prof. R.Y. Patil
Department of Quality Assurance, College of Pharmacy, Solapur, Maharashtra, India.
A simple, rapid and accurate method was developed for the estimation of Argatroban in bulk and in pharmaceutical dosage form and validated. Here, the solutions of Argatroban were prepared in methanol. The standard solution was scanned in the UV range (200-400 nm) in double beam UV spectrophotometer. It’s maximum absorption was found at wavelength 259 nm. Absorbance was measured at 259 nm and calibration curve was plotted as absorbance vs concentration. The method was found to be linear (obeys Beer’s law) in the range of 25-125 ?m/ml . The correlation coefficient was found to be 0.999 and regression of the curve was found as y=0.009x+0.052 with good recovery of 99.37-100.48%. The limit of detection and the limit of quantification were found to be 0.948 ?g/ml and 2.8755 ?g/ml respectively. The ruggedness and robustness were performed. All the parameters of analysis were chosen according to ICH guidelines and were validated statistically using RSD and % RSD with neat chromatograms.All the parameters were found to be satisfactory in accordance with the standard values. The proposed method can be used for routine practice for determination of Argatroban in bulk and in pharmaceutical formulations.