Abstract
Author(s): Vamshi Sharatnath Kaveti1, Vijay Kumar Kema1, Santhoshi Priya Dandamudi2 and Narender Boggula2*
By considering the current regulatory requirement for an analytical method development, a reversed phase high performance liquid chromatographic method for routine analysis of dolasetron in dosage form has been optimized using analytical quality by design approach. A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of dolasetron in injection dosage form. A column Altima (length 150mm, internal diameter 4.6mm; and 5µm particle size) was used. The mobile phase consisting 0.02M di potassium hydrogen orthophosphate buffer pH adjusted to 3 and acetonitrile in the ratio 20:80 (V/V). The flow rate was 1.0 ml/min and the effluents were monitored at 295 nm. The retention time was 11.57 min. The detector response was linear in the concentration of 20-60µg/ml. The respective linear regression equation being Y=3000181x+356238.2. The limit of detection and limit of quantification was 0.5µg/ml and 0.15µg/ml respectively. The assay of dolasetron in bulk was found to be 99.95%. From the recovery studies it was found that about 118.10 % on average of dolasetron was recovered which indicates high accuracy of the method. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of dolasetron in bulk drug and in its pharmaceutical dosage form