Thermal Analysis and Validation of UV and Visible Spectrophotometric Methods for the Determination of New Antibiotic Tigecycline in Pharmaceutical Product

Silva, Lucélia Magalhães da; Almeida, Adélia Emília de; Salgado, Hérida Regina Nunes

doi:10.5923/j.aac.20120201.03

Cited by 6 publications

(6 citation statements)

References 22 publications

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“…LOQ and LOD were found to be 21.09 and 6.96 ng mL −1 , respectively, which indicates the high affectability of the proposed strategy as shown in Table 1 when compared with previously reported methods. [3][4][5][6]…”

Section: Limit Of Detection (Lod) and Limit Of Quantification (Loq)mentioning

confidence: 99%

“…Spectrofluorimetry is preferred as a technique of analysis due to its sensitivity, simplicity, availability and selectivity when compared with other analytical techniques. Further, the proposed approach showed higher sensitivity than previous methods [3][4][5][6] and has been used for the investigation of TIGE in human plasma, urine and pharmaceutical formulation without impedance from complex matrices. In this work, the investigated technique was simply used to study the stability of TIGE in plasma and to study the pharmacokinetic parameters such as maximum concentration of TIGE (C max ), half-life (t 1/2 ) and area under curve (AUC) without matrix interference.…”

mentioning

confidence: 99%

“…Few methods have been reported for analysis of TIGE since its recent introduction to the market, these methods are spectrophotometric, [3,4] spectrofluorimetric, [5,6] and chromatographic [1,7,8] methods.…”

mentioning

confidence: 99%

“…However, major disadvantages have been found in previously reported methods that determine TIGE as lacking in sensitivity and bio-analytical validation, [3][4][5][6] requirement of expensive equipment, skilled persons and disposal of organic solvents. [1,7,8] From the literature, only two spectrofluorimetric methods [5,6] have been reported for determination of TIGE.…”

mentioning

confidence: 99%

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Utility of the fluorogenic characters of benzofurazan for analysis of tigecycline using spectrometric technique; application to pharmacokinetic study, urine and pharmaceutical formulations

et al. 2019

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Tigecycline (TIGE) is the newest tetracycline derivative antibiotic with low toxicity, it is used for management of infectious diseases caused by Gram-positive and Gramnegative bacteria. Hence, an efficient, selective and sensitive method was developed for analysis of TIGE in commercial formulations, human plasma and urine. The spectrofluorimetric technique based on the reaction of secondary amine moiety in TIGE with 4-chloro-7-nitrobenzofurazan (NBD-Cl) in slightly alkaline medium producing a highly fluorescent product measured at 540 nm (λ ex at 470 nm) after heating for 15 min at 75°C. The proposed strategy was upgraded and approved by ICH rules and bio-analytical validated using US-FDA recommendations. A linear relationship between fluorescence intensity and TIGE concentration was observed over the concentration range 40-500 ng mL −1 with limit of quantification (LOQ) 21.09 ng mL −1 and limit of detection (LOD) 6.96 ng mL −1 .The ultra-affectability and high selectivity of the proposed strategy permits analysis of TIGE in dosage form, human plasma and urine samples with good recovery ranged from 97.23% to 98.72% and from 99.36% to 99.80% respectively, without any interfering from matrix components. Also, the developed strategy was used to examine the stability of TIGE in human plasma and applied for pharmacokinetic investigation of TIGE.

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Section: Limit Of Detection (Lod) and Limit Of Quantification (Loq)mentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Utility of the fluorogenic characters of benzofurazan for analysis of tigecycline using spectrometric technique; application to pharmacokinetic study, urine and pharmaceutical formulations

et al. 2019

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“…The Instrument is equipped with variable wavelength UV-VISIBLE detector [7,8] . Data was analysed by using Empower2 software.…”

Section: Instrumentationmentioning

confidence: 99%

Development and Validation of Stability Indicating Rp- HPLC Method for Estimation of Tigecycline in Bulk and Its Parenteral Dosage Forms

Suneetha¹

2017

WJPPS

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The present method describes the development of a validated RP-HPLC method for determination of Tigecycline. Separation was carried out on a Kromasil ODS C-18 column (150×4.6mm, 5µ) using Buffer: Acetonitrile 83: 17 as mobile phase at a flow rate of 1.2 ml/min. UV detection was performed at 247nm. The method was validated with respect to specificity, selectivity, linearity, accuracy, precision and robustness. The assay method was found to be linear in the range of 80 to 120 µg/ml with a correlation coefficient of 0.9999.The percentage recovery of active pharmaceutical ingredient from parenteral dosage form ranged from 99.5 to 100.2%. The results showed that the developed RP-HPLC method is suitable for determination of Tigecycline in bulk as well as stability samples of pharmaceutical dosage forms containing various excipients.

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Utility of eco-friendly microwave-assisted nitrogen-doped carbon dots as a luminescent nano-sensor for the ultra-sensitive analysis of tigecycline in dosage form and biological samples

Salman

2023

Chem. Pap.

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In the presented work, simple, green, sensitive, and selective nitrogen-doped carbon quantum dots (N-CQDs) were developed as nano-sensor for quantification of tigecycline (TIG) in different matrices. The proposed method is based on microwave synthesis of green nitrogen-doped carbon quantum dots with a high quantum yield (41.39%) and size diameter equal to 2.0 nm from the green juice of Eruca sativa leaves. The relative fluorescence intensity (RFI) of the green synthesized quantum dots (N-CQDs) was quenched at emission 512 nm (excitation 445 nm) after the addition of TIG drug. A good linear range between TIG concentration and quenched fluorescence intensity of N-CQDs in the range 20–300 ng mL−1, with the lower limit of quantitation (LOQ) equal to 8.51 ng mL−1. The proposed method was validated using the international conference of harmonization (ICH) recommendation and bio-analytical validation using U.S. food and drug administration (US-FDA) guidelines. The N-CQDs have been fully characterized using a transmission electron microscope (TEM), dynamic light scattering (DLS), X-Ray photoelectron spectroscopy (XPS), and Fourier-transform infrared spectrometer (FTIR). The suggested technique is a straightforward analytical procedure that can be used in clinical laboratories. Under the optimum condition, TIG was estimated in human plasma with a high percentage of recovery ranging from 96.95 to 98.54%. In addition, the proposed method was applied effectively in milk samples with percentage of recovery equal to 98.90 ± 1.55.

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Thermal Analysis and Validation of UV and Visible Spectrophotometric Methods for the Determination of New Antibiotic Tigecycline in Pharmaceutical Product

Cited by 6 publications

References 22 publications

Utility of the fluorogenic characters of benzofurazan for analysis of tigecycline using spectrometric technique; application to pharmacokinetic study, urine and pharmaceutical formulations

Utility of the fluorogenic characters of benzofurazan for analysis of tigecycline using spectrometric technique; application to pharmacokinetic study, urine and pharmaceutical formulations

Development and Validation of Stability Indicating Rp- HPLC Method for Estimation of Tigecycline in Bulk and Its Parenteral Dosage Forms

Utility of eco-friendly microwave-assisted nitrogen-doped carbon dots as a luminescent nano-sensor for the ultra-sensitive analysis of tigecycline in dosage form and biological samples

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