Stress Degradation Studies on Ceftazidime Sodium and Development of a Validated Stability-Indicating HPLC Assay

Lalitha N, S.B.Puranik, Sanjay Pai P.N, Rao G.K.

Abstract: Ceftazidime was subjected to different ICH prescribed stress conditions. The drug was found more stable under neutral, photolytic, 3% oxidative and solid state conditions, while it was found to be less stable under acidic, alkaline and 30% oxidative conditions. A stability-indicating HPLC method was developed for analysis of the drug in the presence of the degradation products. It involved a C-18 column and a mobile phase composed of phosphate buffer pH 6.8 and methanol (10:3), which was pumped through the column in isocratic mode. The detection was carried out at 254 nm. The method was validated for linearity, range, precision, accuracy, specificity, selectivity and intermediate precision.

The parent drug stability test guideline Q1A (R2) issued by International Conference on Harmonization (ICH)1 suggests that stress studies should be carried out on a drug to establish its inherent stability characteristics, leading to identification of degradation products and hence supporting the suitability of the proposed analytical procedures. It also requires that analytical test procedures for stability samples should be stability-indicating and they should be fully validated.

Accordingly, the aims of the present study were to establish inherent stability of ceftazidime through stress studies under a variety of ICH recommended test conditions and, and to develop a stability-indicating assay. The drug is Pyridinium, 1-[[7-[[(2-amino- 4-thiazolyl)[(1-carboxy-1methyle-thoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, innersalt,pentahydrate,[6R-[6a,7b(Z)]] (Fig. 1).4,5 It is a white powder that is soluble in water and practically insoluble in alcohol. It is a semi synthetic 2nd generation cephalosporin with broad-spectrum, beta-lactamase-resistant available in reconstituted formulation.

The literature survey reveals that methods are available for the mechanism of ceftazidime degradation in aqueous solutions, stability of ceftazidime pentahydrate in medicinal preparation biotium and ceftim, reversed-phase HPLC method for determination of the drug in pharmaceutical dosage forms, Determination of Ceftazidime by Thin-Layer Chromatography and Densitometry, First-derivative spectrophotometric and LC determination of ceftazidime and cefadroxil in urine,10 Analysis of antibiotics in urine and wipe samples from environmental and biological monitoring comparison of HPLC with UV, single MS- and tandem MS-detection. Accordingly, a stability-indicating method was developed, which could separate various degradation products. 


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