Development and validation of RP-HPLC method for the estimation of Tigecycline in bulk and its parenteral dosage form

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 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.