A high-performance thin-layer chromatography densitometric method for the separation of isomeric ceftriaxone in powder for injection formulation

Kissa W. Mwamwitwa; Bugusu Nyamweru; Mohamed A. Iwodyah; Gerald Sambu; Goodluck G. Nyondo; Emili Yondu; Adam M. Fimbo; Vicky Manyanga; Wilber Sabiiti; Danstan H. Shewiyo; Morven C. Shearer; Andrew D. Smith; Eliangiringa A. Kaale

doi:10.1038/s41598-024-77334-5

A high-performance thin-layer chromatography densitometric method for the separation of isomeric ceftriaxone in powder for injection formulation

Kissa W. Mwamwitwa^*, Bugusu Nyamweru, Mohamed A. Iwodyah, Gerald Sambu, Goodluck G. Nyondo, Emili Yondu, Adam M. Fimbo, Vicky Manyanga, Wilber Sabiiti, Danstan H. Shewiyo, Morven C. Shearer, Andrew D. Smith, Eliangiringa A. Kaale

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

The aim of this study was to develop and validate a High-Performance Thin Layer Chromatographic (HPTLC) method for simultaneous determination of ceftriaxone and ceftriaxone e-isomer in powder for injection formulation. Ceftriaxone sodium injection is an antibiotic that used globally. It has Z/E geometrical conformation, in which ceftriaxone sodium and 3 ene-isomer have Z- conformation while (E)-isomer has E- conformation and the potential toxicity of ceftriaxone (E)-isomer has been reported. Thus, to safeguard the public health, a simple and easy to use, rapid and reliable method was developed for qualitative and quantitative determination of ceftriaxone sodium and its (E)–isomer. Samples were applied on HPTLC glass plates precoated with silica gel 60F254 by using Linomat semi-auto sampler. Separation was carried out using acetone, triethyl amine, water, chloroform and ethyl acetate as a mobile phase in different ratios. The Rf values of separated compounds were 0.51 ± 0.01 and 0.62 ± 0.01 for ceftriaxone sodium and ceftriaxone (E)-isomer respectively. The method was validated by studying Specificity, Linearity, Accuracy, Precision, Robustness, Limit of Detection (LOD) and Limit of Quantification (LOQ) and Solution stability. The developed method was successfully, sensitive, simple, precise, accurate, robust and applicable for the simultaneous determination of ceftriaxone sodium and ceftriaxone (E)-isomer in powder for injection formulation.

Original language	English
Article number	26308
Number of pages	9
Journal	Scientific Reports
Volume	14
DOIs	https://doi.org/10.1038/s41598-024-77334-5
Publication status	Published - 1 Nov 2024

Keywords

Analytical method validation
Isomers
Ceftriaxone Sodium
High performance thin layer chromatography

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1038/s41598-024-77334-5Licence: CC BY-NC-ND

Mwamwitwa-2024-A-high-performance-SciRep-14-26308-CCBY
Copyright © The Author(s) 2024. This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.
Final published version, 1.36 MBLicence: CC BY-NC-ND

ASCEND: Moving Tanzania's Clinical Research Ethics and Medicines Regulatory Capacity to the next level: Fostering Medicines Quality, Safety and GCP Clinical Trials - ASCEND
Sabiiti, W. (PI) & Shearer, M. (CoI)
6/10/20 → 5/04/23
Project: Standard

Cite this

Mwamwitwa, K. W., Nyamweru, B., Iwodyah, M. A., Sambu, G., Nyondo, G. G., Yondu, E., Fimbo, A. M., Manyanga, V., Sabiiti, W., Shewiyo, D. H., Shearer, M. C., Smith, A. D., & Kaale, E. A. (2024). A high-performance thin-layer chromatography densitometric method for the separation of isomeric ceftriaxone in powder for injection formulation. Scientific Reports, 14, Article 26308. https://doi.org/10.1038/s41598-024-77334-5

@article{7b992cbc024e437f8773f5586fd0eec1,

title = "A high-performance thin-layer chromatography densitometric method for the separation of isomeric ceftriaxone in powder for injection formulation",

abstract = "The aim of this study was to develop and validate a High-Performance Thin Layer Chromatographic (HPTLC) method for simultaneous determination of ceftriaxone and ceftriaxone e-isomer in powder for injection formulation. Ceftriaxone sodium injection is an antibiotic that used globally. It has Z/E geometrical conformation, in which ceftriaxone sodium and 3 ene-isomer have Z- conformation while (E)-isomer has E- conformation and the potential toxicity of ceftriaxone (E)-isomer has been reported. Thus, to safeguard the public health, a simple and easy to use, rapid and reliable method was developed for qualitative and quantitative determination of ceftriaxone sodium and its (E)–isomer. Samples were applied on HPTLC glass plates precoated with silica gel 60F254 by using Linomat semi-auto sampler. Separation was carried out using acetone, triethyl amine, water, chloroform and ethyl acetate as a mobile phase in different ratios. The Rf values of separated compounds were 0.51 ± 0.01 and 0.62 ± 0.01 for ceftriaxone sodium and ceftriaxone (E)-isomer respectively. The method was validated by studying Specificity, Linearity, Accuracy, Precision, Robustness, Limit of Detection (LOD) and Limit of Quantification (LOQ) and Solution stability. The developed method was successfully, sensitive, simple, precise, accurate, robust and applicable for the simultaneous determination of ceftriaxone sodium and ceftriaxone (E)-isomer in powder for injection formulation.",

keywords = "Analytical method validation, Isomers, Ceftriaxone Sodium, High performance thin layer chromatography",

author = "Mwamwitwa, {Kissa W.} and Bugusu Nyamweru and Iwodyah, {Mohamed A.} and Gerald Sambu and Nyondo, {Goodluck G.} and Emili Yondu and Fimbo, {Adam M.} and Vicky Manyanga and Wilber Sabiiti and Shewiyo, {Danstan H.} and Shearer, {Morven C.} and Smith, {Andrew D.} and Kaale, {Eliangiringa A.}",

note = "Funding: The study was part of the EDCTP2 Program supported by the European Union partly under the ASCEND project (CSA2019ERC- 2683) and partly under TMDA.",

year = "2024",

month = nov,

day = "1",

doi = "10.1038/s41598-024-77334-5",

language = "English",

volume = "14",

journal = "Scientific Reports",

issn = "2045-2322",

publisher = "Nature publishing group",

}

Mwamwitwa, KW, Nyamweru, B, Iwodyah, MA, Sambu, G, Nyondo, GG, Yondu, E, Fimbo, AM, Manyanga, V, Sabiiti, W, Shewiyo, DH, Shearer, MC , Smith, AD & Kaale, EA 2024, 'A high-performance thin-layer chromatography densitometric method for the separation of isomeric ceftriaxone in powder for injection formulation', Scientific Reports, vol. 14, 26308. https://doi.org/10.1038/s41598-024-77334-5

TY - JOUR

T1 - A high-performance thin-layer chromatography densitometric method for the separation of isomeric ceftriaxone in powder for injection formulation

AU - Mwamwitwa, Kissa W.

AU - Nyamweru, Bugusu

AU - Iwodyah, Mohamed A.

AU - Sambu, Gerald

AU - Nyondo, Goodluck G.

AU - Yondu, Emili

AU - Fimbo, Adam M.

AU - Manyanga, Vicky

AU - Sabiiti, Wilber

AU - Shewiyo, Danstan H.

AU - Shearer, Morven C.

AU - Smith, Andrew D.

AU - Kaale, Eliangiringa A.

N1 - Funding: The study was part of the EDCTP2 Program supported by the European Union partly under the ASCEND project (CSA2019ERC- 2683) and partly under TMDA.

PY - 2024/11/1

Y1 - 2024/11/1

N2 - The aim of this study was to develop and validate a High-Performance Thin Layer Chromatographic (HPTLC) method for simultaneous determination of ceftriaxone and ceftriaxone e-isomer in powder for injection formulation. Ceftriaxone sodium injection is an antibiotic that used globally. It has Z/E geometrical conformation, in which ceftriaxone sodium and 3 ene-isomer have Z- conformation while (E)-isomer has E- conformation and the potential toxicity of ceftriaxone (E)-isomer has been reported. Thus, to safeguard the public health, a simple and easy to use, rapid and reliable method was developed for qualitative and quantitative determination of ceftriaxone sodium and its (E)–isomer. Samples were applied on HPTLC glass plates precoated with silica gel 60F254 by using Linomat semi-auto sampler. Separation was carried out using acetone, triethyl amine, water, chloroform and ethyl acetate as a mobile phase in different ratios. The Rf values of separated compounds were 0.51 ± 0.01 and 0.62 ± 0.01 for ceftriaxone sodium and ceftriaxone (E)-isomer respectively. The method was validated by studying Specificity, Linearity, Accuracy, Precision, Robustness, Limit of Detection (LOD) and Limit of Quantification (LOQ) and Solution stability. The developed method was successfully, sensitive, simple, precise, accurate, robust and applicable for the simultaneous determination of ceftriaxone sodium and ceftriaxone (E)-isomer in powder for injection formulation.

AB - The aim of this study was to develop and validate a High-Performance Thin Layer Chromatographic (HPTLC) method for simultaneous determination of ceftriaxone and ceftriaxone e-isomer in powder for injection formulation. Ceftriaxone sodium injection is an antibiotic that used globally. It has Z/E geometrical conformation, in which ceftriaxone sodium and 3 ene-isomer have Z- conformation while (E)-isomer has E- conformation and the potential toxicity of ceftriaxone (E)-isomer has been reported. Thus, to safeguard the public health, a simple and easy to use, rapid and reliable method was developed for qualitative and quantitative determination of ceftriaxone sodium and its (E)–isomer. Samples were applied on HPTLC glass plates precoated with silica gel 60F254 by using Linomat semi-auto sampler. Separation was carried out using acetone, triethyl amine, water, chloroform and ethyl acetate as a mobile phase in different ratios. The Rf values of separated compounds were 0.51 ± 0.01 and 0.62 ± 0.01 for ceftriaxone sodium and ceftriaxone (E)-isomer respectively. The method was validated by studying Specificity, Linearity, Accuracy, Precision, Robustness, Limit of Detection (LOD) and Limit of Quantification (LOQ) and Solution stability. The developed method was successfully, sensitive, simple, precise, accurate, robust and applicable for the simultaneous determination of ceftriaxone sodium and ceftriaxone (E)-isomer in powder for injection formulation.

KW - Analytical method validation

KW - Isomers

KW - Ceftriaxone Sodium

KW - High performance thin layer chromatography

U2 - 10.1038/s41598-024-77334-5

DO - 10.1038/s41598-024-77334-5

M3 - Article

SN - 2045-2322

VL - 14

JO - Scientific Reports

JF - Scientific Reports

M1 - 26308

ER -

A high-performance thin-layer chromatography densitometric method for the separation of isomeric ceftriaxone in powder for injection formulation

Abstract

Keywords

UN SDGs

Access to Document

Fingerprint

Projects

ASCEND: Moving Tanzania's Clinical Research Ethics and Medicines Regulatory Capacity to the next level: Fostering Medicines Quality, Safety and GCP Clinical Trials - ASCEND

Cite this