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

Hussien, Emad Mohamed

doi:10.1016/j.bfopcu.2014.08.002

Cited by 8 publications

(7 citation statements)

References 16 publications

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“…This LOQ obtained is approximately 35 times lower than that (1.739 μg/mL) reported for the spectrophotometric method [3]. It is close (0.026 μg/mL) to that reported for HPLC [6].…”

Section: Discussionsupporting

confidence: 71%

Development and Validation of a Spectrofluorimetric Method for the Assay of Tetracycline in Capsules

Namegabe¹,

Sarr²,

Diop³

2018

AJAC

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The purpose of this study is to develop and validate a method for the analysis of tetracycline capsules by spectrofluorimetry. A pH 9 borate buffer was used as diluent of tetracycline after reaction with magnesium salt at the excitation wavelength of 372 nm and 516 nm of emission. A linear response was observed between 0.25 μg/mL and 1.5 μg/mL with a correlation coefficient (R) of 0.9998. The detection and quantification limits found are 0.0125 μg/mL and 0.0412 μg/mL respectively. The proposed method proved trueness with a recovery between 99.88% and 101.10%. The relative standard deviations of repeatability and intermediate precision found ≤2.88% reflected a good precision of the method. The proposed method is therefore valid within the limits of 90% to 110%. The proposed method was applied to the quality control of 9 tetracycline samples from market and gave results in accordance with the pharmacopoeia standards.

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“…This LOQ obtained is approximately 35 times lower than that (1.739 μg/mL) reported for the spectrophotometric method [3]. It is close (0.026 μg/mL) to that reported for HPLC [6].…”

Section: Discussionsupporting

confidence: 71%

Development and Validation of a Spectrofluorimetric Method for the Assay of Tetracycline in Capsules

Namegabe¹,

Sarr²,

Diop³

2018

AJAC

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“…All fiber mats demonstrated burst release of T (Figure 6). There was a slight increase in the concentration of 4-epitetracyline, a degradation product of T [55,56], after 4 months of storage of the fibers (data not shown). Higher degradation of T was observed in PEO-containing fibers, which could be due to the hygroscopic nature of PEO.…”

Section: Drug Loading and Releasementioning

confidence: 92%

Highly Elastic and Water Stable Zein Microfibers as a Potential Drug Delivery System for Wound Healing

et al. 2020

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The development of biomaterials for wound healing applications requires providing a number of properties, such as antimicrobial action, facilitation of cell proliferation, biocompatibility and biodegradability. The aim of the present study was to investigate morphological and mechanical properties of zein-based microfibers, ultimately aimed at creating an environment suitable for wound healing. This was achieved through co-axial electrospinning of core–shell microfibers, with zein protein in the core and polyethylene oxide (PEO) in the shell. Small amounts of PEO or stearic acid were additionally incorporated into the fiber core to modify the morphology and mechanical properties of zein fibers. The presence of PEO in the core was found to be essential for the formation of tubular fibers, whereas PEO in the shell enhanced the stability of the microfibers in water and ensured high elasticity of the microfiber mats. Tetracycline hydrochloride was present in an amorphous form within the fibers, and displayed a burst release as a result of pore-formation in the fibers. The developed systems exhibited antimicrobial activity against Staphylococcus aureus and Escherichia coli, and showed no cytotoxic effect on fibroblasts. Biocompatibility, antimicrobial activity and favorable morphological and mechanical properties make the developed zein-based microfibers a potential biomaterial for wound healing purposes.

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“…It has been marked with a black arrow in Figure 2 . According to the HPLC analyses of tetracyclines carried out by numerous research teams, it can be assumed that this peak corresponds to the product resulting from the epimerization of tetracycline, i.e., 4-epitetracycline [ 9 , 24 , 34 , 35 , 36 , 37 ]. Both the type of product and its content in the studied samples require confirmation with additional analyses.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Influence of a Hydrogel Containing AMPD on the Stability of Tetracycline Hydrochloride

2021

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Tetracyclines, as beneficial antimicrobial factors in both local and systemic therapy, are characterized by high instability. The aim of the study was the development of the influence of hydrogel formulation on the tetracycline hydrochloride (TC) level under varying storage conditions. The HPLC, XPRD as well as SEM and macroscopic observations were involved in the study. The TC concentration decreased within ca. two months from 9.37 µg/mL to 4.41 µg/mL in the case of the photoprotected TC solution stored at 23 °C, whereas the decrease in storage temperature did not improve the final level of TC. In the presence of AMPD, the TC level in aqueous solution decreased drastically to ca. 1 µg/mL. Application of a polyacrylic acid derivative enabled conservation of the TC level through the ca. two months. Thus, the use of alcoholamine in the preparation of the TC hydrogel may result in the development of a therapeutic product with a dual action against acne, including antimicrobial activity and saponification of free fatty acids deposited in the follicles.

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

Cited by 8 publications

References 16 publications

Development and Validation of a Spectrofluorimetric Method for the Assay of Tetracycline in Capsules

Development and Validation of a Spectrofluorimetric Method for the Assay of Tetracycline in Capsules

Highly Elastic and Water Stable Zein Microfibers as a Potential Drug Delivery System for Wound Healing

Evaluation of the Influence of a Hydrogel Containing AMPD on the Stability of Tetracycline Hydrochloride

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