High-performance thin-layer chromatographic determination of satranidazole in its dosage form

A high-performance thin-layer chromatographic method has been developed for determination of a new antiamoebic drug, satranidazole, in a tablet formulation; metronidazole was used as internal standard. The drug was characterized by UV, IR, and NMR spectroscopy and mass spectrometry; purity was analyzed by differential scanning calorimetry. The HPTLC method involves use of silica gel 60F(254) as the stationary phase and chloroform-methanol, 10 + 0.5 (v/v), as mobile phase. The separated bands were detected at lambda = 317 nm. The response was found to be linearly dependent on amount of satranidazole between 200 and 1000 ng. The method was validated to determine its accuracy and precision. System suitability tests were conducted to verify that the resolution and reproducibility were adequate for the analysis. Determination of satranidazole in tablets is described.