RESUMEN
A simple, rapid, precise, and economical spectrophotometric method has been developed for quantitative analysis of Raltegravir Potassium (RALP) in tablet formulations. The stock solution of RALP was prepared in water. The standard solution of RALP in water showed absorption maxima at 331.6 nm. The drug obeyed Beer–Lambert’s law in the concentration range of 1–100 μg/mL with coefficient of correlation (R2) was 0.9999. It showed coefficient of variation below 2 % in intra-run and inter-run precision. The recovery was obtained with values close to the 100 % of theoretical at three different concentrations. The results of analysis have been validated as per ICH guidelines. The method can be adopted in routine analysis of RALP in bulk and tablet dosage form and it involves water as a solvent and no complex extraction techniques.
RESUMEN
The aim of the present work was to develop simple, shorter and effective HPLC method with UV detection (285nm) and subsequent validation for the content uniformity determination of Rabeprazole Sodium in marketed tablet samples. The method uses isocratic mobile phase of 0.1M sodium phosphate buffer (pH adjusted to 6.5 with sodium hydroxide solution) and acetonitrile 65:35 compositions on reverse phase Lichrosphere RP-100 C8 column. The RSD was observed to 0.21 percentage and linearity range of (LOQ) 0.025 – 150 percentage of label claim established with 0.9999 correlation, 8 different brands marketed samples were successfully analysed for content uniformity and compared the results with the USP and other guidelines for acceptance criteria. The developed method was found precise, linear, rugged and robust for validated parameters. The method can be used for assay and the content uniformity determination of Rabeprazole Sodium in its tablet dosage form.