Development and Validation of Spectrophotometric and Liquid Chromatographic Methods for Estimation of Tigecycline in Injections

Abstract

Three new analytical methods were optimized and validated for the estimation of tigecycline (TGN) in its injection formulation. A difference UV spectroscopic, an area under the curve (AUC), and an ultrafast liquid chromatographic (UFLC) method were optimized for this purpose. The difference spectrophotometric method relied on the measurement of amplitude when equal concentration solutions of TGN in HCl are scanned against TGN in NaOH as reference. The measurements were done at 340 nm (maxima) and 410nm (minima). Further, the AUC under both the maxima and minima were measured at 335-345nm and 405-415nm, respectively. The liquid chromatographic method utilized a reversed-phase column (150mm×4.6mm, 5µm) with a mobile phase of methanol: 0.01M KH2PO4 buffer pH 3.5 (using orthophosphoric acid) in the ratio 80:20 %, v/v. The flow rate was 1.0ml/min, and diode array detection was done at 349nm. TGN eluted at 1.656min. All the methods were validated for linearity, precision, accuracy, stability, and robustness. The developed methods produced validation results within the satisfactory limits of ICH guidance. Further, these methods were applied to estimate the amount of TGN present in commercial lyophilized injection formulations, and the results were compared using the One-Way ANOVA test. Overall, the methods are rapid, simple, and reliable for routine quality control of TGN in the bulk and pharmaceutical dosage form.

Simultaneous Determination of Tigecycline and Its Potential Impurities by a Stability-Indicating Rp-HPLC-Uv Detection Technique

“…The established HPLC system was used for the evaluation of the drug with their impurities by in vitro method. Various abstractions were tried to used Methanol, Triethylamine [11,19].…”

Application of Plackett–Burman Design for Spectrochemical Determination of the Last-Resort Antibiotic, Tigecycline, in Pure Form and in Pharmaceuticals: Investigation of Thermodynamics and Kinetics

“…A survey of the literature shows that the majority of the efforts in this regard were dedicated to studying TIGC in terms of its mechanism of action, pharmacokinetics, and pharmacodynamics, with fewer efforts being dedicated to finding a simple analytical technique for the determination of TIGC. The reported techniques mainly included chromatographic-based approaches [ 12 , 13 , 14 , 15 , 16 ] and to a lesser extent spectrophotometric [ 17 ] and spectrofluorimetric [ 18 , 19 ] approaches. By and large, the chromatographic approaches are sophisticated and require well-trained staff.…”