Stability-Indicating TLC-Image Analysis Method for Quantification of Ceftriaxone Sodium in Pharmaceutical Dosage Forms

A simple and rapid thin-layer chromatographic (TLC) image analysis method has been established for stability-indicating studies and quantification of ceftriaxone sodium (CFX) in bulk and in pharmaceutical dosage forms. Chromatographic separation was achieved on RP-18 F(254S) plates with 15% (w/v) ammonium acetate buffer (pH 6.2) methanol acetonitrile 12:0.5:0.25 (v/v) as mobile phase. The method was validated in accordance with International Conference on Harmonization (ICH) guidelines. Polynomial regression data for the calibration plot were indicative of a good linear relationship between response and amount in the range 1-8 mu g per spot. The limits of detection and quantitation were 228 and 759 ng per spot, respectively. The precision, accuracy, and robustness of the method were satisfactory. Good separation was achieved between CFX and the degradation products obtained under different stress conditions, suggesting the method is stability-indicating. The CFX content of dosage forms determined by use of TLC image analysis, TLC densitometry, and the official HPLC method was not significantly different. The proposed TLC method was found to enable reliable and convenient analysis of CFX and can be used as a stability-indicating assay.