A sensitive, selective, precise, and stability-indicating high performance thin layer chromatographic method was developed and validated for the determination of Cefotaxime sodium both as a bulk drug and in formulation. The method uses aluminum plates precoated with silica gel 60 as the stationary phase and F-254 solvent system benzene: methanol: acetic acid 6.5:3.5:0.2, (v/v/v). This system gave compact spot for Cefotaxime sodium (R: 0.55 ± 0.02). Cefotaxime sodium f was subjected to acid and alkali hydrolysis, oxidation, photo, and thermal degradation. The peaks of the degradation products were well resolved from that of the pure drug and had significantly different R values. Densitometric analysis of Cefotaxime sodium was performed in the absorbance mode at 254 nm. The linear f regression analysis data for the calibration plots showed a good linear relationship over a concentration range of 100-600 ng spot−1. The mean values of the correlation coefficient, slope, and intercept were 0.998 ± 0.0015, 3.38 ± 1.47, and 986.9 ± 1.08 respectively. The method was validated for precision, robustness, and recovery. The limit of detection and limit of quantitation were 3.99 and 12.39 ng spot−1, respectively. Statistical analysis showed that the method is repeatable, selective, and can separate the drug from its degradation products and can be used to monitor stability.
Keywords: Cefotaxime sodium; HPTLC; Validation; Stability; Degradation.