Abstract

STABILITY INDICATING CHROMETOGRAPHIC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF MICONAZOLE AND ORNIDAZOLE IN ITS PHARMACEUTICAL DOSAGE FORM BY HPLC

Gameti Nilam Ramanlal* and Darpini Patel

ABSTRACT

An accurate, precise and simple HPLC stability indicating assay method for simultaneous estimation of Miconazole and Ornidazole in their pharmaceutical dosage form has been developed and validated. The best separation was achieved on a C18 (250 mm × 4.6 mm) i.d., 5μm particles, C18reversed phase column with gradient program, Mobile phase Water: Acetonitrile: Acetic acid (30:70;0.1℅v/v), Flow rate 1ml/min, Injection volume 20μl, UV detection was performed at 224 nm. The method was linear over the concentration range of 10- 30μg/ml (r=0.999) and 2-6μg/ml(r=0.999) for Miconazole and Ornidazole, respectively. The limit of detection 0.089μg/ml and 0.457μg/ml for Miconazole and Ornidazole, respectively. The limit of quantification 0.270μg/ml and 1.386μg/ml for Miconazole and Ornidazole, respectively. Forced degradation studies was carried out according to ICH guideline in all condition(Acid hydrolysis, Base hydrolysis, Oxidative degradation, Thermal degradation, Photo degradation).

Keywords: RP-HPLC, Validation, Stability, Miconazole, Ornidazole.