A Simple, selective, accurate, economical reverse phase high performance liquid chromatography (RP-HPLC) was developed for estimation of Raloxifene in pharmaceutical formulations. Chromatographic separation achieved on a C 18 column (Use INERTSIL, C 18 , 5μ, 250×4.6 mm i.d.) with mobile phase containing acetonirile and ammonium acetate buffer in the ratio 75:25 v/v. The flow rate was 1.0 mL/min and effluent was monitored at 254 nm. The retention time was 4.413 min. The method was validated in terms of linearity, accuracy and precision. The linearity curve was found to be linear over 2.5 -12.5 μg/mL. The limit of detection and limit of quantification were found to be 0.0202 and 0.202 μg/ml respectively. The proposed method was successfully used to determine the drug content of marketed formulations.
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.
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