Analytical Method Development and Validation for Simultaneous Estimation of Cefixime Trihydrate and Ornidazole in Tablet Dosage form by RP-HPLC

J. Ramesh Babu*, S. Vidyadhara and V. Anusha

Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chandramoulipuram, Chowdavaram, Guntur - 522 019, India.

Corresponding Author E-mail: ramesh.janga11@gmail.com

DOI : http://dx.doi.org/http://dx.doi.org/10.13005/bbra/1064

ABSTRACT: A simple, specific, and accurate reverse phase high-performance liquid chromatographic method has been developed and validated for the simultaneous determination of Cefixime Trihydrate (CEF) and Ornidazole (ORD) in combined dosage form. Separation was performed on a C18 column [ODS UG 5 column, 250mm x 4.5mm], with methanol: water (50:50 v/v) isocratic elution with a flow rate of 1ml/min. Good sensitivity was observed with UV detection at 298nm. After method development, the influence of different parameters on the separation, the interference of other active compounds and excipients, repeatability and linearity were investigated. The retention times of CEF and ORD were 2.1 and 5.6min respectively and both the drugs showed good linearity in the concentration range of 2-10 µg/mL for CEF with a correlation coefficient (R) of 0.9996 and 5-25 µg/mL for ORD with correlation coefficient (R) of 0.9993 respectively. The proposed method was validated as per ICH guidelines and method showed good precision with percent relative standard deviation less than 2%. The percentage assay values of CEF and ORD were found to be 99.03 and 99.89% respectively and recovery values are within the limits of 98-102% indicating the proposed method was accurate and precise for the simultaneous estimation of CEF and ORD in bulk and pharmaceutical dosage forms.

KEYWORDS: Cefixime Trihydrate (CEF); Ornidazole (ORD); RP-HPLC; Validation.

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