Abstract
A simple stability indicating reversed-phase HPLC method was developed and subsequently validated for estimation of Cefpirome sulphate (CPS) present in pharmaceutical dosage forms. The proposed RP-HPLC method utilizes a LiChroCART-Lichrosphere100, C18 RP column (250 mm × 4mm × 5 μm) in an isocratic separation mode with mobile phase consisting of methanol and water in the proportion of 50:50 % (v/v), at a flow rate 1ml/min, and the effluent was monitored at 270 nm. The retention time of CPS was 2.733 min and its formulation was exposed to acidic, alkaline, photolytic, thermal and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. The described method was linear over a range of 0.5–200μg/ml. The percentage recovery was 99.46. F-test and t-test at 95% confidence level were used to check the intermediate precision data obtained under different experimental setups; the calculated value was found to be less than the critical value.
Highlights
The proposed RP-high-performance liquid chromatography (HPLC) method utilizes a LiChroCART-Lichrosphere100, C18 RP column (250 mm × 4mm × 5 μm) in an isocratic separation mode with mobile phase methanol and water in the proportion of 50:50 % (v/v), at a flow rate 1ml/min and the effluent was monitored at 270 nm
Degradation products resulting from the stress studies did not interfere with the detection of Cefpirome sulphate (CPS), and the assay is stability-indicating
Drug degradation was observed when CPS was treated with mild alkali and a new degradant was eluted at 1.6 min
Summary
Joydeep: β-lactamase resistant fourth generation cephalosporin bearing a quaternary ammonium group at the 3 position of the cephem nucleus. It is used for the treatment of upper and lower urinary tract as well aslower respiratory tract, skin and soft tissue infections. Cefpirome is excreted largely unchanged in the urine with a half-life of 2 hours [1]. It has an expanded spectrum of activity against Pseudomonas sp., enterococci, and staphylococci, as well as other gram-positive and gram-negative bacteria [2]
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