A Rapid Validated RP-HPLC Method for the Simultaneous Determination of Cleaning Validation and Cross Contamination of 12 Beta-Lactam Compounds

Abstract

The present work reports a rapid reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous determination of 12 beta-lactam components for cleaning validation and cross-contamination. A strategic experimental approach was implemented for the method development. The desired chromatographic separation was achieved on a Symmetry C18 (4.6 X 75 mm, 3.5 μm) column using gradient elution. The optimized mobile phase consisted of the buffer tetrabutylammonium hydroxide pH-6.8 and acetonitrile. The eluted compounds were monitored at 215 nm and 254 nm wavelength using a photodiode array detector. The developed method separated 12-beta-lactam compounds from each other within a run time of 50 min. The method is effective for the determination of cross-contamination of penicillin and cephalosporin production blocks. The present method is specific and a lower limit of quantification was determined on the basis of the signal-to-noise ratio method; it is 1 μg/mL for all components. The developed RP-HPLC method was validated according to the International Conference on Harmonization (ICH) guidelines.

Eco-Friendly and Cost-Effective Method for the Quantitative Determination of Ceftriaxone Sodium in Pharmaceutical Drug Formulations

“…Because the usual solution peak occurred sooner than 5 minutes, the overall run time was estimated to be between 8 and 10 minutes. 24,25 Method validation The approach was validated using the British Pharmacopeia (BP), the United States Pharmacopeia (USP), and the International Conference of Harmonization (ICH) guidelines. 22 Linearity, Specificity, Range, Limit of Quantification (LOQ), Limit of Detection (LOD), Precision, and Accuracy were the metrics investigated during the validation.…”