Development and Validation of a UV/vis Spectrometric Method for Determination of Cefixim Trihydrate in Raw Materials (Pure) and Tablet Forms

Mavanga Mabaya Timothy; Mankulu Kakumba Jocelyn; Mayangi Makola Mannix; Mbenza Puati Adelard; Mana Kialengila Didi; Mavar Tayey Mbay Jean; Mbinze Kindenge Jeremi

doi:doi:10.11648/j.ijpc.20210702.12

Development and Validation of a UV/vis Spectrometric Method for Determination of Cefixim Trihydrate in Raw Materials (Pure) and Tablet Forms

Mavanga Mabaya Timothy, Mankulu Kakumba Jocelyn, Mayangi Makola Mannix, Mbenza Puati Adelard, Mana Kialengila Didi, Mavar Tayey Mbay Jean, Mbinze Kindenge Jeremi

Published in International Journal of Pharmacy and Chemistry (Volume 7, Issue 2)

Received: 13 March 2021 Accepted: 30 March 2021 Published: 13 April 2021

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Abstract

A Cefixim Trihydrate method was developed and validated for determination of Cefixim in raw materials and tablets. This was to enable quantification of the compound using an available and less expensive analytical method for those forms. Henceforth, this study aimed to develop and validate a fast, simple and economical Ultraviolet-visible (UV/vis) spectrophotometric method for the quantitative estimation of Cefixim in pure state and in tablet forms. The predicted wavelength for maximal absorption to perform with this method was 286 nm with 0.1N HCl as solvent and blank. This gave useful results for the following steps. Linearity, precision, accuracy, specificity, robustness, limit of detection (LOD) and limit of quantification (LOQ) were evaluated for the method validation according to the International Conference on Harmonization (ICH) requirements. The developed method was used for the quantitative determination of Cefixim tablets marketed on the local market. The calibration data showed a better correlation (R²=1) over the range of concentrations used (2.5-15µg / ml) and the regression equation was Y=0.0511X. The limits of detection (LOD) and quantification (LOQ) determined were 0.275 µg/ml and 0.919 µg/ml, respectively. The accuracy study carried out at three concentration levels (80%, 100%, and 120%) gave respective recovery rate averages of 97.25%, 97.56% and 97.44% at which the relative standard deviations (RSD) were all less than 2%. The intra and inter-day precision, specificity and robustness were also satisfactory.

Published in	International Journal of Pharmacy and Chemistry (Volume 7, Issue 2)
DOI	10.11648/j.ijpc.20210702.12
Page(s)	31-36
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2021. Published by Science Publishing Group

Keywords

Cefixim Trihydrate, UV/vis, Spectrometry, Development, Validation

References

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[5]	Umme Bushra et al., Development and Validation of UV Spectrometric Method for Determination of cefixime trihydrate in Bulk and Pharmaceutical Formulation, Asian Journal of Biomedical and Pharmaceutical Sciences; 3 (22) 2013, 2013, 1-5.
[6]	ICH, Harmonized Tripartite Guideline, Validation of Analytical Procedures, Text and Methodology Q2 (R1). (2004).
[7]	British Pharmacopoeia 2008
[8]	Swiss Accreditation Service SAS, Guide for the validation of chemical-physical test methods and the evaluation of measurement uncertainty, Document No. 324. fW, 2017-11, rev. 03 pp. 22-23.
[9]	Ashutosh Kar, Pharmaceutical Drug Analysis-2005, PP. 83-85.
[10]	Jean Toullec and Monique Mottet, Quantitative chemical analysis of Vogel, pp. 142-147; 662-665.
[11]	Durgesh Rameshlal Parakh, Moreshwar P. Patil, Sandeep S. Sonawane, Chetan P. Jai. Development and validation of spectrophotometric method for estimation of mebendazole in bulk and pharmaceutical formulation, World Journal of pharmaceutical Research, Volume 4, issue 7, 2223-2235, June 2015.
[12]	France Corbeil and Elyse Boivin, Validation of an analytical method, National Institute of Public Health, Quebec Public Health Laboratory, Version 04, pp 16.
[13]	Dange YD, Honmane SM, Bhinge SD, Salunkhe VR, Jadge DR. Development and Validation of UV-Spectrophotometric Method for Estimation of Metformin in Bulk and Tablets Dosage Form. India J of Pharmaceutical Education and Research. 2017; 51 (4S): S754-S60.
[14]	Jain Nilesh (2010) Spectrophotometric Method Development and validation for Quantitative Estimation of Amlodipine Besilate in Bulk Drug and their Dosage Forms by Using Hydrotropic Agent. Eurasian J Anal Chem 5 (3): 212-217.
[15]	Gajjar Anuradha K, Shah VD (2010) Simultaneous UV-spectrophometric Estimation of rosuvastatin and ezetimibe in their combined dosage forms. International of pharmacy and pharmaceutical Sciences 2 (1): 131-138.
[16]	Douglas A. Skoog. F. James HOLLER. Timothy A. NIEMAN. Principles From Instrumental Analysis, Tradition and Revision of the 5th American Edition by Claudine Buess-Herman and Freddy Dumont, 1st Edition, 2nd Edition 2012, pp 868-870.

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APA Style

Mavanga Mabaya Timothy, Mankulu Kakumba Jocelyn, Mayangi Makola Mannix, Mbenza Puati Adelard, Mana Kialengila Didi, et al. (2021). Development and Validation of a UV/vis Spectrometric Method for Determination of Cefixim Trihydrate in Raw Materials (Pure) and Tablet Forms. International Journal of Pharmacy and Chemistry, 7(2), 31-36. https://doi.org/10.11648/j.ijpc.20210702.12

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ACS Style

Mavanga Mabaya Timothy; Mankulu Kakumba Jocelyn; Mayangi Makola Mannix; Mbenza Puati Adelard; Mana Kialengila Didi, et al. Development and Validation of a UV/vis Spectrometric Method for Determination of Cefixim Trihydrate in Raw Materials (Pure) and Tablet Forms. Int. J. Pharm. Chem. 2021, 7(2), 31-36. doi: 10.11648/j.ijpc.20210702.12

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AMA Style

Mavanga Mabaya Timothy, Mankulu Kakumba Jocelyn, Mayangi Makola Mannix, Mbenza Puati Adelard, Mana Kialengila Didi, et al. Development and Validation of a UV/vis Spectrometric Method for Determination of Cefixim Trihydrate in Raw Materials (Pure) and Tablet Forms. Int J Pharm Chem. 2021;7(2):31-36. doi: 10.11648/j.ijpc.20210702.12

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@article{10.11648/j.ijpc.20210702.12,
  author = {Mavanga Mabaya Timothy and Mankulu Kakumba Jocelyn and Mayangi Makola Mannix and Mbenza Puati Adelard and Mana Kialengila Didi and Mavar Tayey Mbay Jean and Mbinze Kindenge Jeremi},
  title = {Development and Validation of a UV/vis Spectrometric Method for Determination of Cefixim Trihydrate in Raw Materials (Pure) and Tablet Forms},
  journal = {International Journal of Pharmacy and Chemistry},
  volume = {7},
  number = {2},
  pages = {31-36},
  doi = {10.11648/j.ijpc.20210702.12},
  url = {https://doi.org/10.11648/j.ijpc.20210702.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijpc.20210702.12},
  abstract = {A Cefixim Trihydrate method was developed and validated for determination of Cefixim in raw materials and tablets. This was to enable quantification of the compound using an available and less expensive analytical method for those forms. Henceforth, this study aimed to develop and validate a fast, simple and economical Ultraviolet-visible (UV/vis) spectrophotometric method for the quantitative estimation of Cefixim in pure state and in tablet forms. The predicted wavelength for maximal absorption to perform with this method was 286 nm with 0.1N HCl as solvent and blank. This gave useful results for the following steps. Linearity, precision, accuracy, specificity, robustness, limit of detection (LOD) and limit of quantification (LOQ) were evaluated for the method validation according to the International Conference on Harmonization (ICH) requirements. The developed method was used for the quantitative determination of Cefixim tablets marketed on the local market. The calibration data showed a better correlation (R2=1) over the range of concentrations used (2.5-15µg / ml) and the regression equation was Y=0.0511X. The limits of detection (LOD) and quantification (LOQ) determined were 0.275 µg/ml and 0.919 µg/ml, respectively. The accuracy study carried out at three concentration levels (80%, 100%, and 120%) gave respective recovery rate averages of 97.25%, 97.56% and 97.44% at which the relative standard deviations (RSD) were all less than 2%. The intra and inter-day precision, specificity and robustness were also satisfactory.},
 year = {2021}
}

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TY  - JOUR
T1  - Development and Validation of a UV/vis Spectrometric Method for Determination of Cefixim Trihydrate in Raw Materials (Pure) and Tablet Forms
AU  - Mavanga Mabaya Timothy
AU  - Mankulu Kakumba Jocelyn
AU  - Mayangi Makola Mannix
AU  - Mbenza Puati Adelard
AU  - Mana Kialengila Didi
AU  - Mavar Tayey Mbay Jean
AU  - Mbinze Kindenge Jeremi
Y1  - 2021/04/13
PY  - 2021
N1  - https://doi.org/10.11648/j.ijpc.20210702.12
DO  - 10.11648/j.ijpc.20210702.12
T2  - International Journal of Pharmacy and Chemistry
JF  - International Journal of Pharmacy and Chemistry
JO  - International Journal of Pharmacy and Chemistry
SP  - 31
EP  - 36
PB  - Science Publishing Group
SN  - 2575-5749
UR  - https://doi.org/10.11648/j.ijpc.20210702.12
AB  - A Cefixim Trihydrate method was developed and validated for determination of Cefixim in raw materials and tablets. This was to enable quantification of the compound using an available and less expensive analytical method for those forms. Henceforth, this study aimed to develop and validate a fast, simple and economical Ultraviolet-visible (UV/vis) spectrophotometric method for the quantitative estimation of Cefixim in pure state and in tablet forms. The predicted wavelength for maximal absorption to perform with this method was 286 nm with 0.1N HCl as solvent and blank. This gave useful results for the following steps. Linearity, precision, accuracy, specificity, robustness, limit of detection (LOD) and limit of quantification (LOQ) were evaluated for the method validation according to the International Conference on Harmonization (ICH) requirements. The developed method was used for the quantitative determination of Cefixim tablets marketed on the local market. The calibration data showed a better correlation (R2=1) over the range of concentrations used (2.5-15µg / ml) and the regression equation was Y=0.0511X. The limits of detection (LOD) and quantification (LOQ) determined were 0.275 µg/ml and 0.919 µg/ml, respectively. The accuracy study carried out at three concentration levels (80%, 100%, and 120%) gave respective recovery rate averages of 97.25%, 97.56% and 97.44% at which the relative standard deviations (RSD) were all less than 2%. The intra and inter-day precision, specificity and robustness were also satisfactory.
VL  - 7
IS  - 2
ER  -

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Author Information

Mavanga Mabaya Timothy

Laboratory of drugs and health products analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa XI, Democratic Republic of the Congo
Mankulu Kakumba Jocelyn

Laboratory of quality control and drugs analysis and diets survey, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa XI, Democratic Republic of the Congo
Mayangi Makola Mannix

Laboratory of quality control and drugs analysis and diets survey, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa XI, Democratic Republic of the Congo
Mbenza Puati Adelard

Laboratory of quality control and drugs analysis and diets survey, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa XI, Democratic Republic of the Congo
Mana Kialengila Didi

Laboratory of quality control and drugs analysis and diets survey, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa XI, Democratic Republic of the Congo
Mavar Tayey Mbay Jean

Laboratory of quality control and drugs analysis and diets survey, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa XI, Democratic Republic of the Congo
Mbinze Kindenge Jeremi

Laboratory of drugs and health products analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa XI, Democratic Republic of the Congo

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APA Style

Mavanga Mabaya Timothy, Mankulu Kakumba Jocelyn, Mayangi Makola Mannix, Mbenza Puati Adelard, Mana Kialengila Didi, et al. (2021). Development and Validation of a UV/vis Spectrometric Method for Determination of Cefixim Trihydrate in Raw Materials (Pure) and Tablet Forms. International Journal of Pharmacy and Chemistry, 7(2), 31-36. https://doi.org/10.11648/j.ijpc.20210702.12

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ACS Style

Mavanga Mabaya Timothy; Mankulu Kakumba Jocelyn; Mayangi Makola Mannix; Mbenza Puati Adelard; Mana Kialengila Didi, et al. Development and Validation of a UV/vis Spectrometric Method for Determination of Cefixim Trihydrate in Raw Materials (Pure) and Tablet Forms. Int. J. Pharm. Chem. 2021, 7(2), 31-36. doi: 10.11648/j.ijpc.20210702.12

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AMA Style

Mavanga Mabaya Timothy, Mankulu Kakumba Jocelyn, Mayangi Makola Mannix, Mbenza Puati Adelard, Mana Kialengila Didi, et al. Development and Validation of a UV/vis Spectrometric Method for Determination of Cefixim Trihydrate in Raw Materials (Pure) and Tablet Forms. Int J Pharm Chem. 2021;7(2):31-36. doi: 10.11648/j.ijpc.20210702.12

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@article{10.11648/j.ijpc.20210702.12,
  author = {Mavanga Mabaya Timothy and Mankulu Kakumba Jocelyn and Mayangi Makola Mannix and Mbenza Puati Adelard and Mana Kialengila Didi and Mavar Tayey Mbay Jean and Mbinze Kindenge Jeremi},
  title = {Development and Validation of a UV/vis Spectrometric Method for Determination of Cefixim Trihydrate in Raw Materials (Pure) and Tablet Forms},
  journal = {International Journal of Pharmacy and Chemistry},
  volume = {7},
  number = {2},
  pages = {31-36},
  doi = {10.11648/j.ijpc.20210702.12},
  url = {https://doi.org/10.11648/j.ijpc.20210702.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijpc.20210702.12},
  abstract = {A Cefixim Trihydrate method was developed and validated for determination of Cefixim in raw materials and tablets. This was to enable quantification of the compound using an available and less expensive analytical method for those forms. Henceforth, this study aimed to develop and validate a fast, simple and economical Ultraviolet-visible (UV/vis) spectrophotometric method for the quantitative estimation of Cefixim in pure state and in tablet forms. The predicted wavelength for maximal absorption to perform with this method was 286 nm with 0.1N HCl as solvent and blank. This gave useful results for the following steps. Linearity, precision, accuracy, specificity, robustness, limit of detection (LOD) and limit of quantification (LOQ) were evaluated for the method validation according to the International Conference on Harmonization (ICH) requirements. The developed method was used for the quantitative determination of Cefixim tablets marketed on the local market. The calibration data showed a better correlation (R2=1) over the range of concentrations used (2.5-15µg / ml) and the regression equation was Y=0.0511X. The limits of detection (LOD) and quantification (LOQ) determined were 0.275 µg/ml and 0.919 µg/ml, respectively. The accuracy study carried out at three concentration levels (80%, 100%, and 120%) gave respective recovery rate averages of 97.25%, 97.56% and 97.44% at which the relative standard deviations (RSD) were all less than 2%. The intra and inter-day precision, specificity and robustness were also satisfactory.},
 year = {2021}
}

Copy | Download

TY  - JOUR
T1  - Development and Validation of a UV/vis Spectrometric Method for Determination of Cefixim Trihydrate in Raw Materials (Pure) and Tablet Forms
AU  - Mavanga Mabaya Timothy
AU  - Mankulu Kakumba Jocelyn
AU  - Mayangi Makola Mannix
AU  - Mbenza Puati Adelard
AU  - Mana Kialengila Didi
AU  - Mavar Tayey Mbay Jean
AU  - Mbinze Kindenge Jeremi
Y1  - 2021/04/13
PY  - 2021
N1  - https://doi.org/10.11648/j.ijpc.20210702.12
DO  - 10.11648/j.ijpc.20210702.12
T2  - International Journal of Pharmacy and Chemistry
JF  - International Journal of Pharmacy and Chemistry
JO  - International Journal of Pharmacy and Chemistry
SP  - 31
EP  - 36
PB  - Science Publishing Group
SN  - 2575-5749
UR  - https://doi.org/10.11648/j.ijpc.20210702.12
AB  - A Cefixim Trihydrate method was developed and validated for determination of Cefixim in raw materials and tablets. This was to enable quantification of the compound using an available and less expensive analytical method for those forms. Henceforth, this study aimed to develop and validate a fast, simple and economical Ultraviolet-visible (UV/vis) spectrophotometric method for the quantitative estimation of Cefixim in pure state and in tablet forms. The predicted wavelength for maximal absorption to perform with this method was 286 nm with 0.1N HCl as solvent and blank. This gave useful results for the following steps. Linearity, precision, accuracy, specificity, robustness, limit of detection (LOD) and limit of quantification (LOQ) were evaluated for the method validation according to the International Conference on Harmonization (ICH) requirements. The developed method was used for the quantitative determination of Cefixim tablets marketed on the local market. The calibration data showed a better correlation (R2=1) over the range of concentrations used (2.5-15µg / ml) and the regression equation was Y=0.0511X. The limits of detection (LOD) and quantification (LOQ) determined were 0.275 µg/ml and 0.919 µg/ml, respectively. The accuracy study carried out at three concentration levels (80%, 100%, and 120%) gave respective recovery rate averages of 97.25%, 97.56% and 97.44% at which the relative standard deviations (RSD) were all less than 2%. The intra and inter-day precision, specificity and robustness were also satisfactory.
VL  - 7
IS  - 2
ER  -

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