The aim of this study is to estimate heavy metals in different brands of amlodipine besylate tablet dosage forms by inductively coupled plasma-mass spectrometry (ICP-MS). In many laboratories around the world as the instrument of choice for performing trace metal analysis is ICP-MS. ICP-MS using Kinetic Energy Discrimination (KED) mode was used. Samples are assimilated using multi-wave sample digestion system. Each element standards of conc. 1000 mg/l was prepared and followed by serial dilution with 2% nitric acid. The validation was performed as per USP232 standards for the different brands of commercially available samples. Parameters such as linearity, accuracy, precision, Limit of detection (LOD), Limit of Quantification (LOQ) were evaluated. Calibration curves were linear and co-relation co-efficient (r 2 ) was 0.995 for all elements. LOD is divided into two components, method detection limit (MDL) and instrumental detection limit (IDL). The MDL limits (in ppb) of 75
Objective: The present study was conducted to develop a simple and precise analytical method for the estimation of Tigecycline in its parenteral formulation.
Methods: Reverse Phase HPLC was used for method development and validation studies of Tigecycline. The optimum chromatographic conditions comprised of C18 column (Kromasil ODS C-18 (150×4.6mm, 5µ) as the stationary phase and 83ml of Buffer (1-Hexane Sulphonic acid Sodium Monohydrate Salt and Potassium Dihydrogen Ortho Phosphate)and 17ml of Acetonitrile in the ratio of 83:17 v/v as the mobile phase. The flow rate was 1.2 ml/min with detection at 247 nm and a run time of 14 MOL2NET, 2018, 4, http://sciforum.net/conference/mol2net-04 2 2 min. Isocratic mode of separation was performed.Results: The retention time of Tigecycline was 7.6 min. The linearity studies indicated that the range of the developed method was 40-60 µg/ml with a correlation coefficient of 0.9999. The method was specific with a percent mean recovery was found to be 100.92%. The % RSD in the Intra-day precision studies was 0.54 and Inter-day precision studies were 0.28. The validated method was applied to conduct the assay of Tigecycline in parenteral dosage form with a percent mean recovery of 101.5%. The Limit of detection and limit of quantification values were found to be 1.8µg/ml and 5.42µg/ml.
Conclusion:The developed and validated RP-HPLC isocratic method was simple, accurate and precise as per the ICH guidelines. It was suitable for the analysis of Tigecycline in bulk and parenteral formulation.
A rapid and simple RP-HPLC chromatographic method has been developed for the estimation of Oxacillin in API and Injectable dosage form. Chromatographic separation was achieved on Phenomenex C18 column (250× 4.6 mm; 5 µm) using 0.1% Ortho -phosphoric acid buffer (pH 6) and acetonitrile in the ratio 50:50 v/v as mobile phase at a flow rate of 1ml/min. The detection wavelength was set as 240 nm. The retention time of the drug was found to be 2.837 min. The method was applied to injectable dosage form, without any interference from excipients. The caliberation curve was linear over the range of 10-150 µg/ml. The performance of the method was validated according to ICH guidelines and it was found suitable for the analysis of oxacillin in routine analysis.
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