Development of a Stability Indicating HPLC Method for Simultaneous Estimation of Ceftriaxone and Sulbactam in Sterile Powder for Injection

Author(s)

Patel, J.R., Bhavsar, A.S., Patel, S.D.

Author's Affiliation

Abstract

A stability indicating HPLC method was developed for the simultaneous determination of Ceftriaxone and Sulbactam in pharmaceutical dosage form. Efficient chromatographic separation was achieved on BDS hypersil C₁₈, 250mm × 4.6mm, 5μ (particle size), Thermo scientific stationary phase with simple combination of a mobile phase containing phosphate buffer (pH 3.5): methanol (60:40 v/v) and quantification was carried out using UV detection at 277 nm at a flow rate of 1.0 ml/min with injection volume of 20μl. This method is capable to detect both the drug components of Ceftriaxone and Sulbactam in presence of their degradation products with detection level of 0.05%. Ceftriaxone and Sulbactam in their combination drug product were exposed to acidic, alkaline, oxidative, thermal and photolytic stress conditions, and the samples were analyzed. Peak homogeneity data of Ceftriaxone and Sulbactam is obtained using standard photo detector, in the stressed sample chromatograms, demonstrating the specificity. The method showed excellent linearity over a range of 10-30% and 5-15% for Ceftriaxone and Sulbactam. The correlation coefficient for Ceftriaxone and Sulbactam were 0.999 and 0.998 respectively. The relative standard deviation was always less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and the stability study of Ceftriaxone and Sulbactam in pharmaceutical preparations. The developed HPLC method was validated with respect to linearity, range, accuracy, precision and robustness.

Keywords

High Performance Liquid Chromatography, Method validation, Stability Indicating Study, Ceftriaxone, Sulbactam

Cite This Article

Patel, J.R., Bhavsar, A.S., Patel, S.D. (2015). Development of a Stability Indicating HPLC Method for Simultaneous Estimation of Ceftriaxone and Sulbactam in Sterile Powder for Injection, International Journal for Pharmaceutical Research Scholars (IJPRS), 4(1), 280-287.