World Journal of
Pharmaceutical and Life Sciences

STABILITY-INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF OZENOXACIN AND ITS DEGRADATION PRODUCTS IN OINTMENT DOSAGE FORMS

Jaish Raza Madni*, Aejaz Ahmed, Khan G. J. and Khan Juber

ABSTRACT

The present work was the development of a simple, efficient, and reproducible stability-indicating reverse-phase high performance liquid chromatographic (RP-HPLC) method for determination of Ozenoxacin and its degradation products. Including Alkaline Hydrolysis impurity ranging 11.01 %, Acid, Hydrolysis impurity ranging 11.61 % and Oxidation impurity ranging 14.76 % using ointment dosage form. The separation of Ozenoxacin and its degradation products in ointments was carried out on Kromasil C-18 (250 × 4.6 mm, 5 ????m) column using Water. Flow rate was 0.7 mL min?1 with a column temperature of 35 ?C and detection wavelength was carried out at 307 nm. The forced degradation studies were performed on Ozenoxacin ointment under acidic, basic, oxidative, thermal, humidity, and photolytic conditions. The degraded products were well resolved from the main active drug and also from known impurities within 1 hr. The method was validated in terms of specificity, linearity, LOD, LOQ, accuracy, precision, and robustness as per ICH guidelines. The results obtained from the validation experiments prove that the developed method is a stability-indicating method and suitable for routine analysis.

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