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Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC AND UV-SPECTROSCOPIC METHOD OF ECONAZOLE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Neha R. Patil*, Sunil P. Pawar and Vipul H. Jain

ABSTRACT

An Analytical method development and its validation is an important aspect in drug discovery process. a new, simple and rapid reversed-phase high-performance liquid chromatography (HPLC) method and UV-Spectroscopic method were developed and validated for the determination of Econazole in bulk and pharmaceutical dosage form. The UV- spectroscopic determination was done at an absorption maximum of 260 nm. A linear response was observed in the range of 2-10μg/ml with regression coefficient of 0.997. The method was then validated for different parameters as per the ICH guidelines. RP-HPLC method was performed by using a mobile phase consisting mixture of acetonitrile : water 0.05%PH 3 Adjusted with OPA in the proportion 70:30v/v. (Cosmosil) C18 column (4.6mm x 250mm,5μm) used as a stationary phase. HPLC analysis of Econazole was carried out at a wavelength of 260 nm with a flow rate of 0.7ml/min. The linear regression analysis data for the calibration curve showed good relationship with coefficient 0.999. The method was validated for different parameters as per the guidelines.

Keywords: Econazole, method development, RP-HPLC, UV-Spectroscopic, validation.


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