Validation of a Stability-Indicating RP-LC Method for the Determination of Tigecycline in Lyophilized Powder

Abstract

A reversed-phase liquid chromatography (RP-LC) method was validated for the determination of tigecycline in lyophilized powder. The LC method was conducted on a Luna C18 column (250 × 4.6 mm i.d.), maintained at room temperature. The mobile phase consisted of buffer containing sodium phosphate monobasic (0.015M) and oxalic acid (0.015M) (pH 7.0)-acetonitrile (75:25, v/v), run at a flow rate of 1.0 mL/min and using ultraviolet detection at 280 nm. The chromatographic separation was obtained with a retention time of 8.6 min, and was linear in the range of 40-100 µg/mL (r(2) = 0.9997). The specificity and stability-indicating capability of the method was proven through forced degradation studies, which also showed no interference of the excipients. The accuracy was 99.01% with a bias lower than 1.81%. The limits of detection and quantitation were 1.67 and 5.05 µg/mL, respectively. Moreover, method validation demonstrated satisfactory results for precision and robustness. The proposed method was applied for the analysis of the lyophilized powder formulation, contributing to improve the quality control and to assure the therapeutic efficacy.

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

“…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].…”

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

“…2 Literature survey reveals that there are only limited reported methods for analysis of Tigecycline using UV-Visible Spectrophotometry 3,4 and RP-HPLC. [5][6][7][8] Also there are few RP-HPLC 9,10 and LC-MS/MS [11][12][13][14] methods for analysis of Tigecycline in biological samples. The present research work describes the development and validation of a simple, rapid, accurate and precise UV Spectroscopic method for estimation of Tigecycline in bulk and pharmaceutical formulation.…”

Development and validation of a quality by design enabled robust LC method for estimation of daptomycin in pharmaceutical dosage form

“…examined level of variability in quantifying melatonin in plants and plant cultures[13]. However, the variables of the reported method were chosen without any systematic scouting from a pool of variables . For chromatographic method variables such as mobile phase composition, mobile phase flow rate, pH of the mobile phase, detection wavelength, solvents, column and instrument of different manufacturers, equilibration time etc can be studied.…”