LC determination of rosiglitazone in bulk and pharmaceutical formulation.
ABSTRACT 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.
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ABSTRACT: The thin‐layer chromatographic behavior of new oral antidiabetic drugs, pioglitazone, rosiglitazone, and repaglinide has been investigated. For reversed‐phase (RP) chromatography, chemically bonded cyanopropyl plates with mobile phases comprising 1,4‐dioxane with phosphate buffers were used. The influence of the pH on the separation of the drugs was also examined. Then, a simple, rapid, and stability‐indicating high performance thin‐layer chromatographic method has been developed and validated for the quantitative determination of pioglitazone in tablets. Analysis was performed with 1,4‐dioxane–phosphate buffer of pH 4.4 (5:5) as the mobile phase. Detection and quantification were performed by classical densitometry at the wavelength of maximum absorption of pioglitazone, 266 nm. A calibration plot was constructed in the range of 0.4–2.4 µg/10 µL and was linear with a good correlation coefficient (r = 0.9957). Precision was validated by replicate analyses of standard solutions, and accuracy by analysis of fortified samples. The precision of the proposed chromatographic method expressed as mean relative standard deviation (RSD) was 4.99% and 2.57%, respectively, for the lowest and the highest calibration levels. Recovery from the fortified samples ranged from 98.09% to 103.28%. The mean (±SD) recovery from tablets was 99.79% ± 1.57%.Journal of Liquid Chromatography & Related Technologies - J LIQ CHROMATOGR RELAT TECHNO. 01/2005; 27(13):2057-2070.
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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.
- Jpc-journal of Planar Chromatography-modern Tlc - JPC-J PLANAR CHROMAT-MOD TLC. 01/2006; 19(110):288-296.