DEVELOPMENT & VALIDATION OF STABILITY-INDICATING METHOD FOR DETERMINATION OF THE RELATED SUBSTANCE OF CEFTRIAXONE IN CEFTRIAXONE FOR INJECTION USP BY RP-HPLC

Kinnar Patel, Ujjwal Shaoo, Ashim Kumar Sen, A Seth, Dhanya Sen
2013 unpublished
A simple stability-indicating, reverse phase liquid chromatographic method has been developed for the determination of related substance (chromatographic purity) of Ceftriaxone (CTX) in Ceftriaxone for injection USP. The analysis was carried out by using Inertsil ODS-3V (250 × 4.6mm), 5µm column. Eluted by gradient programming using mobile phase A, Buffer: Acetonitrile (ACN) (93:7 v/v) & mobile phase B as ACN at a flow rate of 1.5ml/min & were monitored using UV detector at 254nm with the
more » ... ion volume of 10µL, with a runtime of 45minutes. The stability indicating capability of the method was proven by subjecting the drug to stress condition such as acid & base hydrolysis, oxidation, photolytic and thermal, resolution of the degradation products formed therein. The described method is accurate & linear over a range of about 0.18µg/ml to 3.81 µg/ml. The method precision for the determination of related substance was below 5.0% RSD. The % RSD for the impurities in dosage forms was ranged from 0.9% to 1.3%. LOD & LOQ of all related impurities of CTX was established and ranged from 10.9%-12.9% (NMT 30%) for LOD and 0.1%-0.7% (NMT 10%) for LOQ. Hence, the present method stands validated and can be used for routine quality control and stability studies.
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