Abstract

DEVELOPMENT AND VALIDATION OF UV- SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF DOMPERIDONE IN API AND PHARMACEUTICAL DOSAGE FORM

Neha Ranjeet Gate*, Dr. Mallinath Shankarappa Kalshetti, Kaveri Chandrakant Dulange, Zeba Mahamad Hanif Gaibu and Shubhangi Sidram Bamgonde

ABSTRACT

A rapid, simple, selective, sensitive, precise and specific UV Spectrophotometric method has been developed for the determination of Domperidone in API and pharmaceutical dosage form. Domperidone standard solution was scanned in the UV range (200-400nm) in 1cm quartz cell in a double beam UV Spectrophotometer. The spectrophotometric detection was carried out at an absorption maximum of 288 nm using Methanol as a solvent. The method was validated for specificity, linearity, accuracy, precision, robustness and ruggedness. The detector response for the Domperidone was linear over the selected concentration range 5-25 μg /ml with a correlation coefficient of 0.999 and equation for the regression curve was found to be y=0.0297x+0.115. The accuracy was between 99-101%. The precision (%RSD) among six samples preparation was 0.308 %. The LOD and LOQ are 0.045 And 0.1 μg /ml respectively. Statistical analysis proved that the methods are repeatable and specific for the determination of the said drug. These methods can be adopted in the routine assay analysis of Domperidone in API and pharmaceutical dosage form.

Keywords: Domperidone, Methanol, Method Validation.