Abstract

DEVELOPMENT OF A NEW CHROMATOGRAPHIC METHOD FOR ESTIMATION OF DOLASETRON IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

B. Raju* and P. Silas

ABSTRACT

Background: A simple, accurate and precise HPLC method for simultaneous determination of Dolasetron in pure and tablet dosage form has been developed. Aim: Development Of A New Chromatographic Method For Estimation Of Dolasetron In Bulk And Pharmaceutical Dosage Form By Rp-Hplc. Materials and Methods: HPLC of Waters (Model: Alliance 2695) with Phenomenex Luna C18 (4.6 mm I.D. × 250 mm, 5 μm) column was used for chromatographic separation. It contains waters injector and PDA Detector (Deuterium). Mobile phase consists of Acetonitrile: Water (50:50% v/v)) and flow rate adjusted was 1ml/min. Wavelength selected for detection was 285nm and injection volume was 10 μl. Results and discussion: By using the developed method, retention time of Dolasetron was found to be 3.008 respectively. The method has been validated for linearity, accuracy and precision. Linearity of Dolasetron were in the range 10– 50μg/ml respectively. The percentage recoveries obtained for Dolasetron were found to be in range of 99.6 LOD and LOQ were found to be 1.16μg/ml and 3.5μg/ml for Dolasetron. Conclusion: A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Dolasetron, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6 x 250mm, 5μm) column using a mixture of Acetonitrile and Water (50:50% v/v) as the mobile phase at a flow rate of 0.8ml/min, the detection was carried out at 285nm. The retention time of the Dolasetron was 3.0 ±0.02min. The method produce linear responses in the concentration range of 10-50ppm of Dolasetron. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Dolasetron; PDA Detection; RP-HPLC; Validation; Tablet dosage forms.