Development and Validation of a HPTLC Method for Simultaneous Densitometric Analysis of Cefixime and Potassium Clavulanate as the Bulk Drugs and in the Tablet Dosage Form

A new simple high performance thin layer chromatographic (HPTLC) method for simultaneous determination of Cefixime and Potassium Clavulanate combined tablet dosage form has been developed and validated. The separation was carried out on Merck aluminum plates precoated with silica gel 60 F₂₅₄, using Acetone: Water: Acetic acid 8:0.8:1.2 (v/v/v) as mobile phase. The separated spots were stained with Iodine vapors and scanned at 410 nm. The retention factor for Cefixime and Potassium Clavulanate were found to be 0.23±0.01 and 0.68±0.01. The method was validated with respect to linearity, accuracy, precision, robustness, in accordance with ICH guidelines. The calibration curve was found to be linear over a range of 0.5-3.0 μg per spot for Cefixime and 0.310-1.870 μg per spot for Potassium Clavulanate. The method has been successfully applied for the analysis of drugs in pharmaceutical formulation. The % assay (Mean±S.D.) was found to be 100.29±0.9933 for Cefixime and 100.95±1.005 for Potassium Clavulanate.