Method Development, Validation and Forced Degradation Studies for Determination of Tigecycline in Bulk and Pharmaceutical Dosage Form using UV Spectroscopy

Abstract

Objective: The present research work aimed to develop and validate a simple, rapid, accurate and reproducible UV Spectroscopic method for the quantitative estimation of Tigecycline in bulk and pharmaceutical dosage form. Method: The method was developed using Acetonitrile as diluent. The wavelength of maximum absorbance (λmax) of Tigecycline was found to be 250nm. Validation of the developed method was performed according to International Conference on Harmonisation (ICH) guidelines on validation of analytical procedures: text and methodology Q2(R1). Assay of Tigecycline marketed formulation was performed and the amount of drug was determined. Forced degradation studies were performed by subjecting Tigecycline to stress conditions such as acid & base hydrolysis, oxidation, thermal degradation and photolysis. The degraded samples were further analyzed by using the developed method to determine the degradation behavior and the amount of Tigecycline degraded. Results: The method was found to be linear over the concentration range of 2-30μg/ ml with correlation coefficient (r2) 0.999. The analytical method showed good precision with % Relative Standard Deviation (%RSD) below 2. All the other validation parameters such as accuracy, Limit of Detection (LOD) & Limit of Quantification (LOQ), robustness and ruggedness were found to be within the limits. The drug degraded more under thermal stress condition. Conclusion: The developed method is simple, rapid with accuracy and reproducibility therefore it can be applied for the routine analysis of Tigecycline in bulk and pharmaceutical dosage form. Key words: Forced degradation, Tigecycline, UV Spectroscopy, Method development, Validation.