An analytical method based on isocratic reverse phase high-performance liquid chromatography was developed and validated for the separation and quantification of eight antidiabetic drugs: rosiglitazone, pioglitazone, glipizide, gliclazide, repaglinide, nateglinide, glibenclamide, and glimepiride for their application in human plasma assay. Metformin is used as internal standard. Analysis was done on Onyx monolithic C18 column (100 × 4.6 mm, i.d., 5 μm) using a mixture of 0.05% formic acid in water and methanol in the ratio of 42 : 58 (v/v) fixed at a flow rate of 0.5 mL/min, and they were monitored at 234 nm. Separation was achieved in less than 20 min. The calibration curves were linear in the range of 50–2000 ng/mL. The method was validated for its recovery, intra- and interday precision, stability, specificity, and selectivity. Plasma samples were prepared using solid-phase extraction of analytes. Hence, the developed method was found to be suitable for the routine analysis of selected antidiabetic drugs in biological matrices.
KEYWORDSVoglibose is a potent glucosidase inhibitor used for type II diabetes mellitus. A simple and rapid high performance liquid chromatographic method with refractive index detection was developed for the determination of voglibose in pharmaceutical formulations. Development was performed on a C18 (250 x 4.6 mm, 5 µ) column using a mobile phase mixture of acetonitrile and water in the ratio of 50:50 which was fixed at a flow rate of 0.5 mL/min. Polarity of voglibose was found to be positive and elution time was found to be less than 5 min. The method was also validated as per ICH guidelines for its linearity, precision, accuracy and robustness. The limit of detection and quantification (LOD and LOQ) were found to be 2.91 and 9.7 µg/mL. The method could be successfully applied for the quantification of voglibose in pharmaceutical formulations. Voglibose HPLC RID Validation Pharmaceutical formulations
A simple reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of rosiglitazone (RGL) and gliclazide (GLC) in pure and pharmaceutical dosage forms. A phenomenex Gemini reverse phase C 18 column (150x4.6mm i.d., 5µ) was used with a mobile phase containing a mixture of acetonitrile and water (pH 3 adjusted with ortho phosphoric acid) in the ratio of 70: 30. The flow rate was 0.6mL/min. and effluents were monitored at 250nm and eluted at 2.41min. (RGL) and 5.22min. (GLC). Calibration curve was plotted with a range from 0.025-2.5µg/mL for RGL and 0.08 to 8µg/mL for GLC. The assay was validated for the parameters like accuracy (>97.87% recovery), precision (intra-day and inter-day with %RSD < 2), robustness and system suitability parameters. Hence the method was found to suitable for the routine quality control of the drugs in pure and pharmaceutical dosage forms.
A rapid and sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) method has been developed for quantitative determination of Tamsulosin (TMS). The analyte was extracted from human plasma by Liquid-Liquid Extraction (LLE) using Methyl Tertiary Butyl Ether (MTBE) and Dichloromethane (DCM). Tolteridone Tartrate (TLT) was used as the internal standard. A Phenomenex RP-18 (50 x 4.6 mm i.d., 5µ) column provided chromatographic separation of the analyte using a mobile phase containing Acetonitrile: 0.01M ammonium formate (pH9.0) (90:10) at a flow rate of 0.8 ml/min with an elution time as low as 3.0 min which was followed by detection with mass spectrometry. The Multiple Reaction Monitoring (MRM) pair (m/z) 409.3/271.4 for TMS and 326.4/147.1 for TLT. Simple isocratic chromatographic conditions and mass spectrometric detection of the method enables the detection of TMS at less than nanogram levels. The proposed method was found to be linear from 0.20-100.08 ng/ ml. The precision and accuracy values are within 10%. The overall recovery of TMS was 90.92 %.
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