VALIDATED INHERENT STABILITY-INDICATING HPLC-DAD METHOD FOR SIMULTANEOUS DETERMINATION OF PAMABROM AND PARACETAMOL IN MARKETED FORMULATION

摘要

A simple, rapid, precise and accurate isocratic reversed-phase stability-indicating HPLC with diode array detection method was developed and validated for the simultaneous determination of Pamabrom (PBM) and Paracetamol (PCM) in commercial tablets.PBM and PCM were degraded together under different stress test conditions prescribed by International Conference on Harmonization.The samples generated were used to develop a stability-indicating high performance liquid chromatographic (HPLC) method for both the drugs.The drugs were well separated from degradation products using a reversed-phase C 18 (4.6 x 250mm, 5渭m particle size) column with isocratic elution of the mobile phase comprising of water: methanol: acetonitrile, in the ratio of 70:20:10 v/v/v.The mobile phase flow rate was maintained at 1.0 ml/min with the detection wavelength used for quantification of PBM and PCM was 279 nm.The drugs were subjected to different stress conditions like neutral, acidic and alkaline hydrolysis, oxidation, photolysis and thermal degradation.Degradation products produced was a result of stress studies did not interfered with the detection of PCB and PCM, thus the assay can thus be considered stability-indicating.Analytical performance of the proposed HPLC procedure was thoroughly validated with respect to system suitability, linearity, range, precision, accuracy, specificity, robustness, detection and quantification limits.The developed procedure is also applicable to the determination of instability of the drugs in commercial formulations.