Abstract

TO DEVELOP AND VALIDATE A NOVEL ANALYTICAL METHOD FOR ESTIMATION OF IN-VITRO DISSOLUTION DRUG RELEASE OF DOLASETRON BY USING RP- HPLC

Imad Ul Haq. Md*, Sujatha Palatheeya and Raju Badhavath

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Abstract

A rapid and precise reverse phase high performance liquid chromatography method has been developed and validated as per current regulatory approaches, to estimate the percentage drug release of the dissolution in dolasetron tablet dosage form. Chromatography was carried out on a kinetex XB C18 (150X4.6mm,2.6μ) column using a mixture of acetonitrile and phosphate buffer (50:50v/v) as the mobile phase at a flow rate of 0.8mL/min, the detection was carried out at 215nm. The retention time of the dolasetron was about 3min and the run time was 8min. The method produces linear response to the concentration ranges of 25-125ppm of dolasetron. The recovery was done 25% of the lower strength to 150% of higher strength on the active component. In this study the dissolution method has been optimized by different approaches as per the current regulatory guidelines. The method precision for the determination of % drug release in dissolution media 0.1N HCl at 30min time point. The above 90% of the drug release has been achieved with %RSD below 3.0%. The method can be able to evaluate the invitro % drug release of dolasetron for the commercial marketed drug product.

Keywords: Dolasetron, RP-HPLC, Validation, Dissolution and Regulatory guideline.