Pharmaceutical and chemical industry Zdravlje Actavis

Leskovac, Serbia

Pharmaceutical and chemical industry Zdravlje Actavis

Leskovac, Serbia
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Savic I.,University of Niš | Nikolic G.,University of Niš | Marinkovic V.,Pharmaceutical and chemical industry Zdravlje Actavis
Chemical Industry and Chemical Engineering Quarterly | Year: 2010

A selective, precise and stability-indicating, modified high performance liquid chromatographic method for the analysis of sodium picosulfate both as a bulk drug and in formulations was developed and validated. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one. The chromatographic separation was achieved on a ZORBAX Eclipse XDB C-18 analytical column. The mobile phase consisted of phosphate buffer (pH 7):acetonitrile (85:15 v/v). The absorbance was monitored with a DAD detector at 263 nm. The flow rate was 1.5 mL min-1. Statistical analysis proved the method is repeatable, selective, and accurate for estimation of sodium picosulfate in the presence its degradation product. Forced degradation studies were performed on bulk sample of sodium picosulfate using heat (25, 40, 60 and 80 °C) and oxidation (0.1, 0.5 and 1% v/v hydrogen peroxide). The proposed method was successfully applied, with excellent recovery, to the analysis of a pharmaceutical formulation (Sodium picosulfate, Zdravlje-Actavis, Serbia).


Milenkovic M.Z.,Pharmaceutical and Chemical Industry Zdravlje Actavis | Marinkovic V.D.,Pharmaceutical and Chemical Industry Zdravlje Actavis | Sibinovic P.S.,Pharmaceutical and Chemical Industry Zdravlje Actavis | Palic R.M.,University of Mis | Milenovic D.M.,Pharmaceutical and Chemical Industry Zdravlje Actavis
Journal of the Serbian Chemical Society | Year: 2010

An HPLC method for digoxin quantification in dissolution samples obtained as per the official British Pharmacopeia (BP) method is presented in this paper. The chromatography was performed at 20 °C on a Symmetry C18; 3.5 μm, 75 mm×4.6 mm column with water-acetonitrile (72:28, v/v), as the mobile phase and UV detection at 220 nm. The method was found to be selective, linear, accurate and precise in the specified ranges. The LOD and LOQ were 0.015 and 0.050 mL -1, respectively. Robustness testing was conducted to evaluate the impact of minor changes in the chromatographic parameters (i.e., acetonitrile fraction, flow rate of the mobile phase, column temperature and column length) on the characteristics of the digoxin peak. A full factorial design (2 4) was used to investigate the influence of the four variables The presented HPLC method was applied in quality and stability testing of digoxin tablets 0.25 mg. 2010 Copyright (CC) SCS.

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