Estimation of Related Substances in Tigecycline by rp-hplc Method

Abstract

Estimation of related substancesby usinghigh-performance liquid chromatographic method was developed and validated for the determination of Tigecycline in the present work. Reversedphase chromatography was performed on Waters 2489 UV 2695 pump, Waters 2998 PDA 2695 pump Software Empower 2 photodiode array detector using Zorbax Eclipse plus C18 (100 mm × 4.6 mm, 1.8 µm particle size) column with eluent-A: pH 6.50 buffer: acetonitrile: DMSO (90:5:5 %v/ v/v) and eluent-B: pH 6.50 buffer: acetonitrile: DMSO (71:24:5 %v/v/v) as mobile phase at a flow rate of 1.0 mL/min. with UV detection at 270 nm.Linearity was observed in the concentration range of Tigecycline LOQ-1.13% (R2 = 1.000), the concentration range of di-MA-TIG impurity 0.04-0.23% (R2 = 1.000), the concentration range of CMI 0.05-0.23% (R2 = 0.999). The limit of quantitation (LOQ) and limit of detection (LOD) were found to be di-MA-TIG impurity 0.0001 and 0.0004mg/ mL, CMI impurity 0.0001and 0.0004µg/mL, Tigecycline 0.0001and 0.0005mg/mL respectively. The method was validated as per ICH guidelines. The %RSD precision was found to be less than 1.0 %. The percentage recovery was in good agreement with the labeled amount in the pharmaceutical formulations and the method is simple, specific, precise and accurate for the determination of Tigecycline in pharmaceutical formulations.

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

“…Detected system suitability parameters and tabulated parameters were satisfactory and reported theoretical plate count values, tail factor and resolution values are tabulated in (table 3). Retention time in the present study is comparable to the studies of De Silva et al [8] and Suneetha et al [9] but less than Mohan et al 2017 [12].…”

“…2) for simultaneous determination of Tigecycline and its related impurities (impirity 1 and imp 2). λmax is lower in the present study (231 nm) compared to the studies carried out by other researchers like De Silva et al [8] Suneetha et al [9] Hua XI et al [11] Mohan et al 2017 [12] and Zorpas et al [14] where λmax was in the range of 247 to 270 nm.…”

“…The literature survey for the estimation of Tigecycline confirms that few HPLC [8][9][10][11][12] and one UV spectrophotometer [13] assay methods reported for the estimation of Tigecycline in pharmaceutical formulations. One bio-analytical method was reported for the estimation of Tigecycline in rabbit plasma [14].…”

Central composite design driven optimization of sustainable stability indicating HPLC method for the determination of Tigecycline and greenness assessment

“…Degradation kinetic study ICH Q1A (R1) and Q1B recommendations were applied further to study the degradation of TGC under various stress conditions. 10,48 Reagents/instruments Report method (a) 33 Report method (b) 34 Report method (c) 35 The proposed method (d) . GAPI evaluation of the green character of the reported method 1 (A), reported method 2 (B), reported method 3 (C) and developed HPLC method (D).…”

“…9,10 TGC was previously determined using spectrophotometric methods, 11 fluorescence determination, [12][13][14] and liquid chromatography coupled with ultraviolet and mass spectrometry detection in human plasma [15][16][17][18][19][20][21][22][23][24][25][26] and pharmaceutical preparations. [27][28][29][30][31][32] Other methods, such as stability-indicating, [33][34][35][36][37][38][39] have also been used to determine the drug's parenteral dosage form. The bulk of these processes take significant time, are harmful to the surrounding ecosystem, and require using acetonitrile as a mobile phase.…”