ICH Guidelines.

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.

Albendazole (ALB), chemically known as methyl [5-(propylthio)-1H-benzimidazol-2-yl] carbamate is widely used as an anthelmintic having a wide spectrum of activity. Numerous numbers of analytical methods are there for the simultaneous estimation of bulk and in formulation, such as spectrophotometry and liquid chromatography. As the UV spectrophotometric method is rapid, simple, accurate and economical, the method has been developed for the assay of the albendazole in pharmaceutical formulation. The wavelengths selected for the method were at 291 nm. The results of analysis have been validated by recovery studies as per ICH guidelines. The developed method was rapid, simple, accurate and economical and it can be used for routine quality control analysis. It showed absorption maxima at 291 nm in analytical grade DMF. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity.