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.
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