STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF DOMPERIDONE AND NAPROXEN IN BULK AND TABLET DOSAGE BY RP HPLC

A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validation of Domperidone and Naproxen in its pure form as well as in tablet dosage form. Chromatography was carried out on a Phenomenex Gemini C18 (4.6×250mm) 5µ column using a mixture of Acetonitrile: Water (10:90 v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 264nm. The retention time of the Domperidone and Naproxen was 2.121, 3.643 ±0.02 mins, respectively. The method produced linear responses in the concentration range of 5-25µg/ml of Domperidone and 25-125µg/ml of Naproxen. 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. The results have showed that Domperidone and Naproxen and the other degradation products were fully resolved and thus the method is stability-indicating. The developed method can be successfully employed for the routine analysis of Domperidone and Naproxen in API and Pharmaceutical dosage forms.

Key Words: Domperidone, Naproxen, RP-HPLC, validation