Development and validation of stability-indicating HPLC method for simultaneous estimation of cefixime and linezolid
Department of Quality Assurance Techniques, Parul Institute of Pharmacy, Limda Ta, Waghodiya, Dist., Vadodara 391 760, India
Nidhi S Patel Department of Quality Assurance Techniques, Parul Institute of Pharmacy, Limda Ta, Waghodiya, Dist., Vadodara 391 760 India E‑mail: [email protected]
A stability-indicating reverse phase high performance liquid chromatography method was developed and validated for cefixime and linezolid. The wavelength selected for quantitation was 276 nm. The method has been validated for linearity, accuracy, precision, robustness, limit of detection and limit of quantitation. Linearity was observed in the concentration range of 2-12 μg/ml for cefixime and 6-36 μg/ml for linezolid. For RP-HPLC, the separation was achieved by Phenomenex Luna C 18 (250×4.6 mm) 5 μm column using phosphate buffer (pH 7):methanol (60:40 v/v) as mobile phase with flow rate 1 ml/min. The retention time of cefixime and linezolid were found to be 3.127 min and 11.986 min, respectively. During force degradation, drug product was exposed to hydrolysis (acid and base hydrolysis), H 2 O 2 , thermal degradation and photo degradation. The % degradation was found to be 10 to 20% for both cefixime and linezolid in the given condition. The method specifically estimates both the drugs in presence of all the degradants generated during forced degradation study. The developed methods were simple, specific and economic, which can be used for simultaneous estimation of cefixime and linezolid in tablet dosage form.