JuniperPublishers | Annals of Reviews & Research

Stability Indicating Rp-HPLC Method for Simultaneous Estimation of Ceftazidime Pentahydrate and its Impurity Product Pyridine in Powder Used for Making Solution in Vial for 1M & IV Injections



Authored by MEM Hassouna

A new, sensitive, precise, simple, and stability indicating RP-HPLC method is developed and validated for simultaneous estimation of Ceftazidime pentahydrate(CFZ) and its impurity product Pyridine(PY) in powder which is used for making solution in vial for intramuscular (IM) & intravenous (IV) injections. The RP-HPLC method is performed on the Atlantis dc18 column (150 mm X 4.6 mm, 5^m particle size, using buffer solution of pH 7.0 containing 0.02 M anhydrous sodium acetate: acetonitrile (60:40 v/v) as the mobile phase at a flow rate of 1.5 mL/min, injection volume 20 ^L and UV detection at 254 nm. The total run time is 5.0 min.Linear relationships are obtained in the ranges of 100-400 μg/ mL and 5-50μg/mL for CFZ and PY, respectively, with significantly different Rt values of 1.456and 2.970min for the two studied drugs. Correlation coefficients (r) >0.9999, limits of detection 3.40 and 0.16 μg mL-1and limits of quantitation of 10.33 and 0.49 μg mL-1have been obtained for CFZ and PY, respectively. The suggested method is validated according to ICH guidelines. Hence it is suitable for laboratory control of starting materials, bulk and finished products.


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