Development and Validation of a High-Performance Liquid Chromatographic Determination of Ceftriaxone Sodium and Its Application to Drug Quality Control

Abstract

A reliable and sensitive RP-HPLC method was developed and validated for the quantitative estimation of ceftriaxone sodium (CFTZ) in pure drug and pharmaceutical dosage forms. The separation of ceftriaxone sodium was achieved on a Waters XTerra RP-18 (5 µm, 250 × 4.6 mm i.d.) column using photodiode array detector at 240 nm. The mobile phase consisted of 0.1 M triethylammoniumacetate–acetonitrile (60:40 v/v) mixture delivered at a flow rate of 1.0 ml/min. Accuracy, evaluated by means of the spike recovery method, was excellent, with percent recovery in the range 99.5–102% with precision in the range 0.3–1.2%.

Keywords:

• Ceftriaxone sodium
• dosage forms
• RP-HPLC

Notes

NA–Not available.

VS–Visible spectrophotometry.

^a Y = a + bC, where ‘C’ is concentration of drug in µg/ml.

^a Mean value of five determinations.

^b Based on peak area.

^a Mean ± SD, n = 5.

Tabulated t-value at 95% confidence level is 2.77.

Tabulated F-value at 95% confidence level is 6.39.

^a Mean ± SD, n = 3.