Development of validated RP-HPLC methods for quantification of donepezil and ranolzine from the in-house formulations

Abstract

A simple, accurate, rapid, precise and novel Reverse phase High Pressure liquid chromatographic method (RP-HPLC)
has been developed and validated for simultaneous determination of Donepezil & Ranolzine from the in-house
formulations. Chromatographic separation for Donepezil was performed on Agilient Zorbax C18 (150x 4.6 mm,) 5µm
at a wavelength of 220 nm using a isocratic program for 10 min, by using mobile phase of OPA buffer solution and
Methanol in the ratio of 60:40v/v pH 3.0. Donepezil obeys linearity in the range of 2 to 20µg/ml. The retention time was
found to be 6.184 min. Chromatographic separation for Ranolzine was performed on Phenomenex Zorbax C18 (250x
4.6 mm,) 5µm at a wavelength of 220 nm using a isocratic program for 15 min, by using mobile phase of Potassium
Phosphate buffer solution and Methanol in the ratio of 35:65v/v pH 7.0. Ranolzine shows linearity in the range of 25
to175µg/ml. The retention time was found to be 10.454 min. The proposed chromatographic conditions were found
appropriate for the quantitative determination of the drugs. The method was validated for accuracy, precision,
specificity, linearity, robustness, sensitivity, LOD and LOQ. The proposed method was successfully used for
quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed.
Validation studies revealed that method is specific, rapid, reliable, and reproducible.