Publications (2)0 Total impact
Article: Spectrophotometric Determination of Isoxsuprine Hydrochloride as Base Form in Pharmaceutical Formulation through Charge Transfer Complexation[show abstract] [hide abstract]
ABSTRACT: Two simple and selective spectrophotometric methods are described for the determination of isoxsuprine hydrochloride (ISX·HCl) as base form in bulk drug and in injections and tablets. The methods are based on the molecular charge-transfer complexation of ISX base (ISX) with either p-chloranilic acid (PCA) or 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ). The intense colored radical anions formed on dissociation, are quantitated at 520 nm (PCA method) or 600 nm (DDQ method). The optimum assay conditions were optimized. Beer's law is obeyed in the concentration ranges 5.28 × 10–5 to 42.2 × 10–5 mol dm–3 in PCA method and 0.79 × 10–5 to 10.6 × 10–5 mol dm–3 in DDQ method, with respective molar absorptivity values of 1.32 × 103 and 6.55 × 103 dm3 mol–1 cm–1. The reaction stoichiometry in both methods was evaluated by either Job’s method or limiting logarithmic method and was found to be 1:1 (ISX: PCA, ISX: DDQ). Developed methods were validated according to ICH guidelines and found to be accurate and precise.Croatica Chemica Acta (CCA@chem.pmf.hr); Vol.83 No.4.
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ABSTRACT: A rapid, sensitive and selective method for the determination of raloxifene hydrochloride (RLX) in pure drug and in tablets was developed using gradient high performance liquid chromatography (HPLC). The devised method involved separation of RLX on a reversed phase Hypersil ODS column and determination with UV detection at 284 nm. The standard curve was linear (R = 0.999) over the concentration range of 50-600 μg mL1 with a detection limit of 0.04 μg mL1 and a quantification limit of 0.16 μg mL1. Intra-day and inter-day precision and accuracy of the method were established according to the current ICH guidelines. Intra-day RSD values at three QC levels (250, 450 and 550 μg mL1) were 0.20.5% based on the peak area. The intra-day relative error (er) was between 0.2 and 0.5%. The developed method was successfully applied to the determination of RLX in tablets and the results were statistically compared with those obtained by a literature method. Accuracy, evaluated by means of the spike recovery method, was excellent with percent recovery in the range 97.7103.2 with precision in the range 1.62.2%. No interference was observed from the conformulated substances. The method was economical in terms of the time taken and the amount of solvent used.Acta pharmaceutica (email@example.com); Vol.58 No.3.