Accuracy

A new, simple, accurate, precise and robust isocratic RP-HPLC method has been developed and subsequently validated for the determination of Regorafenib in pure form and pharmaceutical dosage forms as per ICH guidelines. The separation achieved on a Symmetry C18 Column, 250 mm x 4.6 mm i.d. and 5µm particle size column as a stationary phase and Methanol: Phosphate buffer (pH adjusted to 4.80 with phosphoric acid) in the ratio of 70:30v/v used as mobile phase at a flow rate of 1.0 ml/min. The UV detection was performed at 268nm. The retention time for Regorafenib was found to be 3.544minutes. The detector response was linear in the concentration range of 0-16µg/ml. The respective linear regression equation being Y= 58945.x + 9634 with R2 = 0.999. The percentage of Regorafenib in pharmaceutical dosage form was found to be within the limits. The limit of detection and the limit of quantification were found to be 0.90µg/ml and 2.90µg/ml respectively. The results of the study showed that, the proposed RP-HPLC method was simple, rapid, precise, accurate and stability indicating, which can be used for the routine determination of Regorafenib in pure form and pharmaceutical dosage forms.

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Ranolazine in tablet dosage form. The drug is freely soluble in analytical grade methanol. The drug was identified in terms of solubility studies and on the basis of melting point which was done on melting point apparatus of Equiptronics. Ranolazine showed absorption maxima were determined in analytical grade methanol. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Ranolazine in tablet dosage form and also validated as per ICH guidelines. The drug is freely soluble in analytical grade methanol, slightly soluble acetonitrile and very slightly soluble in analytical grade water. So, the analytical grade methanol is used as a diluent in method. The melting point of Ranolazine was found to be 120-122ËšC (uncorrected). It showed absorption maxima 235 nm in analytical grade methanol. On the basis of absorption spectrum the working concentration was set on 8 µg/ml (PPM). The linearity was observed between 2-12 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101 and 98.33% for three levels respectively. The % RSD for precision was found to be 0.6353% which was within acceptance criteria as per ICH guidelines. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Ranolazine in tablet dosage form. The method could be considered for the determination of Ranolazine in tablet dosage form in quality control laboratories.