A Review on Analytical Methods for Tigecycline Estimation from Its Bulk and Dosage Form.

Abstract

Tigecycline (TIG) is a third-generation glycylcycline derivative used as an antimicrobial and anticancer agent for the past few years. Its intricate structure makes it more vulnerable towards degradation under the influence of various environmental factors and leads to the generation of impurities. Due to its stability issues, TIG is available as a lyophilized powder for injection. The analysis of TIG becomes a cumbersome task for the analysts due to its instability in solution form. As TIG works as a life-saving drug, it's important to review its analytical methods for its quality control. The present review discusses various analytical methodologies for determining TIG from its bulk, lyophilised powder, and pharmacopeial methods for determining its impurities. Further, the factors responsible for the instability of TIG are briefly mentioned, along with its physicochemical properties. Numerous alternative analytical techniques such as UV-visible spectrophotometry, spectrofluorimetric methods, RP-HPLC (Reversed-Phase High-Performance Liquid Chromatography) and FT-IR (Fourier Transform Infra-Red), electrophoresis has been reported for quantification, identification and characterisation of TIG. Several analytical techniques are available to be used as a quality control tool for tigecycline, including HPLC without derivatisation, whereas the fluorescence technique requires derivatisation using acidic dye. Few methods require tedious pre-sample preparation techniques; become time-consuming, and involve using one or more organic solvents, there is a need to develop eco-friendlier methods for analysing tigecycline.