HPTLC METHOD FOR ESTIMATION OF DRONEDARONE HYDROCHLORIDE IN BOTH BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

The objective of the current study was to develop a validated, specific HPTLC method for the quantitative determination of Dronedarone and its related substances Simple, accurate and precise high-performance thin-layer chromatography (HPTLC) method for the simultaneous determination of Dronedarone in both, bulk drug and tablet dosage form has been developed and validated. Chromatographic separation was carried out on silica gel 60 GF254 HPTLC plates with Acetone:Methanol (8:2, v/v) using as solvent system. The method validated for accuracy, precision, specificity, Linearity, Range, limit of detection (LOD) and limit of quantification (LOQ). The calibration curve was found to be linear in the concentration range of 200-800 ng/band with Correlation co-efficient is 0.999. Sensitivity of the method was carried out by LOD and LOQ, and was found 34.6 and 75.2 ng/band respectively. Method is specific, selective with potential application in pharmaceutical analysis in tablet dosage form.