Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DOXYCYCLINE MONOHYDRATE AND ORNIDAZOLE IN COMBINED TABLET DOSAGE FORM.

Satishkumar Shetty A, Surya K S*, Manzoor Ahmed, Anil Kumar S M, Vijaya Krishna C Aradhya, Ravi M C.

ABSTRACT

The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method and subsequently validate as per ICH guidelines for the determination of Doxycycline monohydrate (DOXY) and Ornidazole (ORNI) using mobile phase [A mixture of Phosphate buffer- pH-3.6 and acetonitrile in the ratio of 35:65 was considered to be the optimal composition] as the solvent. The proposed method involves the measurement of retention time at selected analytical wavelength. 228.0 nm was selected as the analytical wavelength. The retention time of DOXY and ORNI was found to be 5.106 and 5.548 respectively. The linearity of the proposed method was investigated in the range of 2-10 μg/ml (r = 0.9999) for DOXY and 10-50 μg/ml (r = 0.9998) for ORNI respectively. The method was statistically validated for its linearity, accuracy and precision. Both inter-day and intra-day variation was found to be showing less % RSD (Relative Standard Deviation) value indicating high grade of precision of the method.

Keywords: RP-HPLC method, Doxycycline monohydrate, Ornidazole, Validation.