An isocratic reversed phase liquid chromatographic (RP-LC) method has been developed and subsequently validated for the determination of rosiglitazone and its related impurities. Separation was achieved with a Symmetry C18 column and sodium phosphate buffer (pH adjusted to 6.2):acetonitrile (50:50, v/v) as eluent, at a flow rate of 1.0 ml/min. UV detection was performed at 245 nm. The method is simple, rapid, selective and stability indicating. Indole was used as internal standard for the purpose of quantification of rosiglitazone. The described method is linear over a range of 0.45-10 microg/ml for related impurities and 180-910 microg/ml for assay of rosiglitazone. The method precision for the determination of assay and related compounds was below 1.0 and 3.6% RSD, respectively. The mean recoveries of impurities were found to be in the range of 95-102%. The percentage recoveries of Active Pharmaceutical Ingredient (API) from dosage forms ranged from 99.02 to 101.30. The method is useful in the quality control of bulk manufacturing and also in pharmaceutical formulations.
[Show abstract][Hide abstract] ABSTRACT: Rimonabant is an antiobesity drug which is CB1 cannabinoid receptor antagonist. Its main avenue of effect is reduction in appetite. So far only HPLC methods of analysis exist for the routine examination of drug. An attempt is hereby made to develop a simple spectrophotometric method for determination of drug from tablet dosage form. Rimonabant shows a maximum absorbance at 230 nm. Beer's law was obeyed in the concentration range of 10-25 µg/ml. The method was validated statistically and recovery studies carried out.
[Show abstract][Hide abstract] ABSTRACT: The considerations behind the selection of reversed phase stationary phases in the pharmaceutical sciences and industry is reviewed throughout the various stages of drug development, from the lead discovery to the manufacturing stage. The selection of the appropriate stationary phase and column in every stage, according to the analytical needs, is described.
Journal of Liquid Chromatography & Related Technologies 01/2004; 27(7-9-27):1-24. DOI:10.1081/JLC-120030606 · 0.61 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: A simple, rapid, and precise reversed-phase liquid chromatographic method is developed for the simultaneous determination of metformin in combination with rosiglitazone. This method uses a Zorbax XDB C(18) 15-cm analytical column, a mobile phase of acetonitrile and buffer containing 10mM disodium hydrogen phsosphate, and 5mM sodium dodecyl sulphate in the ratio of 34:66 (v/v), and pH is adjusted to 7.1 with orthophosphoric acid. The instrumental settings are a flow rate of 1 mL/min, column temperature at 40 degrees C, and detector wavelength of 226 nm. The internal standard method is used for the quantitation of metformin and rosiglitazone. Methylparaben is used as an internal standard. The method is validated and shown to be linear. The correlation coefficients for metformin and rosiglitazone are 0.9996 and 0.9997, respectively. The relative standard deviation for six replicate measurements in two sets of each drug in the tablets is always less than 2%.
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