Development and Validation of Stability Indicating Spectroscopic Method for Content Analysis of Ceftriaxone Sodium in Pharmaceuticals.

Revathi Ethiraj,Venkattapuram Saravanan Sampath,Ethiraj Thiruvengadam,Jithin Raj,Abdul Vahid

doi:10.1155/2014/278173

Revathi Ethiraj, Venkattapuram Saravanan Sampath + Show 3 more

Open Access

https://doi.org/10.1155/2014/278173

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Abstract

A simple, selective, and stability indicating spectroscopic method has been selected and validated for the assay of ceftriaxone sodium in the powder for injection dosage forms. Proposed method is based on the measurement of absorbance of ceftriaxone sodium in aqueous medium at 241 nm. The method obeys Beer's law in the range of 5–50 μg/mL with correlation coefficient of 0.9983. Apparent molar absorptivity and Sandell's sensitivity were found to be 2.046 × 103 L mol−1 cm−1 and 0.02732 μg/cm2/0.001 absorbance units. This study indicated that ceftriaxone sodium was degraded in acid medium and also underwent oxidative degradation. Percent relative standard deviation associated with all the validation parameters was less than 2, showing compliance with acceptance criteria of Q2 (R1), International Conference on Harmonization (2005) guidelines. Then the proposed method was successfully applied to the determination of ceftriaxone sodium in sterile preparation and results were comparable with reported methods.

Highlights

Ceftriaxone sodium (Figure 1) is chemically (6R,7R)-7[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-ioxo-1,2,4-triazin-3-yl)thio]-methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene2-carboxylic acid [1]
Least square regression equation of ceftriaxone sodium in aqueous medium has shown that the R2 value very close to 1 indicated high degree of correlation between two variables, such as absorbance and concentration (Figure 3)
Beer’s law was obeyed over the range of 5–50 μg/mL; high values of molar absorptivity and low values of Sandell’s sensitivity and Limit of Detection (LOD) revealed that proposed methods are highly sensitive

Summary

Introduction

Ceftriaxone sodium (Figure 1) is chemically (6R,7R)-7[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-ioxo-1,2,4-triazin-3-yl)thio]-methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene2-carboxylic acid [1]. Ceftriaxone is a third generation, semisynthetic cephalosporin antibiotic. Cephalosporins are derivatives of 7-aminocephalosporic acid and are closely related to penicillins in structure. Ceftriaxone sodium is a long acting, broad-spectrum cephalosporin antibiotic for parenteral use. The bactericidal activity of ceftriaxone sodium results from inhibition of cell wall synthesis. It exerts in vitro activity against a wide range of Gram-negative and Gram-positive microorganisms. It is highly stable to most beta-lactamases, both penicillinases and cephalosporinases, of Gram-positive and Gram-negative bacteria

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