Collaborative Study of the Analysis of Tetracycline by Liquid Chromatography on Poly(Styrene-Divinylbenzene)

Hendrix, Christel; Roets, Eugène; Crommen, Jacques; Beer, Jacques O. De; Porqueras, E.; Bossche, W. Van den; Hoogmartens, Jos

doi:10.1080/10826079308019651

Cited by 13 publications

(6 citation statements)

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Section: Introductionmentioning

confidence: 98%

“…Thus, none of these methods can be recommended as a compendium method for the assessment of tetracycline and its degradates. Other chromatographic methods had been reported for the separation and assessment of tetracycline hydrochloride and its related compounds (Hendrix et al, 1993;Khan et al, 1990;Wolfs et al, 1986;Tsuji and Robertson, 1976), but they are tedious and employ older columns. This paper describes a simple, fast, reliable reversed-phase gradient HPLC method for modernizing USP tetracycline hydrochloride-related monographs and general chapter <226>.…”

Section: Introductionmentioning

confidence: 99%

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Development and validation of an HPLC method for tetracycline‐related USP monographs

Hussien

2014

Biomedical Chromatography

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A novel reversed-phase HPLC method was developed and validated for the assay of tetracycline hydrochloride and the limit of 4-epianhydrotetracycline hydrochloride impurity in tetracycline hydrochloride commercial bulk and pharmaceutical products. The method employed L1 (3 µm, 150 × 4.6 mm) columns, a mobile phase of 0.1% phosphoric acid and acetonitrile at a flow rate of 1.0 mL/min, and detection at 280 nm. The separation was performed in HPLC gradient mode. Forced degradation studies showed that tetracycline eluted as a spectrally pure peak and was well resolved from its degradation products. The fast degradation of tetracycline hydrochloride and 4-epianhydrotetracycline hydrochloride in solution was retarded by controlling the autosampler temperature at 4 °C and using 0.1% H3 PO4 as diluent. The robustness of the method was tested starting with the maximum variations allowed in the US Pharmacopeia (USP) general chapter Chromatography <621>. The method was linear over the range 80-120% of the assay concentration (0.1 mg/mL) for tetracycline hydrochloride and 50-150% of the acceptance criteria specified in the individual USP monographs for 4-epianhydrotetracycline hydrochloride. The limit of quantification for 4-epianhydrotetracycline hydrochloride was 0.1 µg/mL, 20 times lower than the acceptance criteria. The method was specific, precise, accurate and robust.

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Section: Introductionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

Development and validation of an HPLC method for tetracycline‐related USP monographs

Hussien

2014

Biomedical Chromatography

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“…The new method proved specific, linear, accurate and precise for the drug substance and oral suspension. The advantage of this method over other HPLC methods [3][4][5][6][7][8][9][10][11][12][13] and other electrophoretic methods 14,15 is that it is simple, specific and uses advanced instrumentations which are available in all laboratories for routine analysis. Thus, it can be recommended as a compendium method.…”

Section: Introductionmentioning

confidence: 99%

HPLC method validation for modernization of the tetracycline hydrochloride capsule USP monograph

Hussien

2014

Bulletin of Faculty of Pharmacy, Cairo University

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This paper is a continuation to our previous work aiming at development and validation of a reversed-phase HPLC for modernization of tetracycline-related USP monographs and the USP general chapter <226>. Previous results showed that the method is accurate and precise for the assay of tetracycline hydrochloride and the limit of 4-epianhydrotetracycline impurity in the drug substance and oral suspension monographs. The aim of the current paper is to examine the feasibility of the method for modernization of USP tetracycline hydrochloride capsule monograph. Specificity, linearity, accuracy and precision were examined for tetracycline hydrochloride assay and 4-epianhydrotetracycline limit. The method was linear in the concentration range from 80% to 160% (r>0.9998) of the assay concentration (0.1 mg/mL) for tetracycline hydrochloride and from 50% to 150% (r>0.997) of the acceptance criteria specified in tetracycline hydrochloride capsule monograph for 4-epianhydrotetracycline (NMT 3.0%). The recovery at three concentration levels for tetracycline hydrochloride assay was between 99% and 101% and the RSD from six preparations at the concentration 0.1 mg/mL is less than 0.6%. The recovery for 4-epianhydrotetracycline limit procedure over the concentration range from 50% to 150% is between 96% and 102% with RSD less than 5%. The results met the specified acceptance criteria.ª 2014 Production and hosting by Elsevier B.V. on behalf

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“…Several papers dealing with the liquid chromatographic determination of tetracyclines and their degradation products have been published [11,12]. Those reports deal mainly with the determination of tetracyclines in pharmaceutical preparations, where relatively high concentrations are involved, but it is also important determine their presence in biological and food samples at residual levels.…”

Section: Introductionmentioning

confidence: 99%

Determination of tetracycline and its major degradation products by liquid chromatography with fluorescence detection

Pena

López-Carmona

Barbosa

et al. 1998

Journal of Pharmaceutical and Biomedical Analysis

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A liquid chromatographic method of tetracycline and its major degradation products on a C8-reversed phase column with acidic mobile phase and fluorescence detection is described. The quantification limit, measured as the amount of sample that gave a signal ten times the peak-to-peak noise of the baseline, was: 0.25 ng for tetracycline (TC) and epitetracycline (ETC), 25 ng for and 4-epianhydrotetracycline (EATC) and 50 ng for anhydrotetracycline (ATC) of injected standard. By means of this liquid chromatography (LC) assay TC, ETC, EATC and ATC as main degradation products of tetracycline, can be separated and determined with good sensitivity and specificity within 15 min.

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Collaborative Study of the Analysis of Tetracycline by Liquid Chromatography on Poly(Styrene-Divinylbenzene)

Cited by 13 publications

References 1 publication

Development and validation of an HPLC method for tetracycline‐related USP monographs

Development and validation of an HPLC method for tetracycline‐related USP monographs

HPLC method validation for modernization of the tetracycline hydrochloride capsule USP monograph

Determination of tetracycline and its major degradation products by liquid chromatography with fluorescence detection

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