Ceema Mathew¹*, Shashikala Metri², Bejjanki Jahnavi¹, Bukya Rekha¹, Shakapuram Neha¹ and Battula Prasanna¹

¹Department of Pharmaceutical Analysis, Gokaraju Rangaraju College of Pharmacy, Bachupally, Hyderabad, Telangana, 500090, India
²Department of Pharmacognosy, Gokaraju Rangaraju College of Pharmacy, Bachupally, Hyderabad, Telangana, 500090, India

*Corresponding Author: Ceema Mathew, Professor, Department of Pharmaceutical Analysis, Gokaraju Rangaraju College of Pharmacy, Bachupally, Hyderabad, Telangana, 500090, India.

Received: September 25, 2025; Published: September 30, 2025

Abstract

Procedures for the cephalosporine antibiotic, Ceftriaxone, were devised and validated to be simple, accurate, and exact. It is based on a visible spectrophotometric analysis of Ceftriaxone using Ninhydrin, which reacts with Ceftriaxone's aromatic amino group to form a purple chromogen. The reaction at 90˚C for 30 minutes produced a chromogen with a λmax of 568.5 nm. Beer-Lambert's law applies to 10 to 100 μg/ml concentrations. The limit of detection (LOD) and limit of quantification (LOQ) values were 1.54 and 4.67 μg/mL, respectively. This approach was validated in accordance with ICH criteria, and the results indicated that the procedures were appropriate for routine quality control of pharmaceuticals in bulk medications and pharmaceutical formulations.

Keywords: Ceftriaxone; Ninhydrin; Colorimetric Method; Spectrophotometric Validation; LOQ; LOD

References

1. "Ceftriaxone". DrugBank. Accessed September (2025).
2. Lakshmi KS and Nithya Mathi N. "Spectrophotometric Methods for the Estimation of Ceftriaxone Sodium in Vials”. International Journal of Pharmaceutical Sciences1 (2009): 22-25.
3. Rind, F.M.A and M.G.H. Laghari. "Spectrophotometric Determination of Ceftriaxone Using 4-Dimethylamino Benzaldehyde”. Pakistan Journal of Analytical and Environmental Chemistry 9 (2008): 43-48.
4. Bhaskar Reddy CM and GV Subbareddy. "Development and Validation of UV-Spectrophotometric Methods for Estimation of Ceftriaxone in Bulk and Tablet Dosage Form”. International Journal of ChemTech Research 5 (2013): 472-477.
5. Aswani Kumar CH and AH Menon. "Colorimetric Determination of Cefadroxil and Ceftriaxone in Pharmaceutical Dosage Forms”. Tropical Journal of Pharmaceutical Research 2 (2014): 81-88.
6. Verdier MC., et al. "A Simple and Rapid HPLC-UV Method for Quantification of β-Lactam Antibiotics (Including Ceftriaxone) in Plasma”. Antimicrobial Agents and Chemotherapy7 (2011): 3317-3322.
7. Palanikumar B and Abu Tariq. "An RP-HPLC Method for Simultaneous Estimation of Ceftriaxone Sodium and Sulbactam Sodium in Injection Dosage Form”. International Journal of Pharmacy and Pharmaceutical Sciences 2 (2010): 32-36.
8. Shrivastava Sanjay Mohan and Rajkumar Singh. "A Novel High Performance Liquid Chromatographic Method for Simultaneous Determination of Ceftriaxone and Sulbactam in Sulbactomax”. International Journal of Biomedical Science 2 (2009): 37-49.
9. Shrestha, B., et al. "UHPLC Method for Simultaneous Determination of Ceftriaxone and Tazobactam in Plasma”. Biomedical Chromatography 27 (2013): 101-106.
10. Campos ML., et al. "Development and Validation of an UHPLC Method for the Determination of Ceftriaxone in Human Plasma”. Journal of Chromatography B 1040 (2017): 173-179.
11. Mukap M., et al. "Development of a Dried Blood Spot Assay for Ceftriaxone by Liquid Chromatography-Tandem Mass Spectrometry”. Journal of Chromatography B 1072 (2018): 90-96.
12. Ongas M., et al. "LC-MS/MS Quantitation of Ceftriaxone in Human Plasma and Dried Blood Spots”. Journal of Pharmaceutical and Biomedical Analysis 145 (2017): 692-698.
13. International Conference on Harmonisation (ICH). “Validation of Analytical Procedures: Text and MethodologyQ2(R1)” (2005).

Citation

Citation: Ceema Mathew., et al. “Development and Validation of a Visible Spectrophotometric Method for Ceftriaxone using Ninhydrin". Acta Scientific Pharmaceutical Sciences 9.10 (2025): 50-56.

Copyright

Copyright: © 2025 Ceema Mathew., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.