Purpose:
The aim of the present study was to establish the
inherent stability of cefazolin through stress studies
under a variety of ICH recommended test conditions and,
also to develop a stability indicating assay.
Methods:
A
stability-indicating HPLC assay method was developed and
validated for cefazolin using an isocratic RP-HPLC
method which employed an SS Wakosil II- C18
column (250 mm × 4.6 mm i.d., 5 µm) with a mobile phase
consisting of phosphate buffer (pH 6.8) and methanol
(5:2 v/v), and UV detection at 254 nm at a flow rate of
1 ml/min. The stress testing of cefazolin was carried
out under acidic, alkaline, neutral, oxidation and
thermal conditions.
Results:
The drug peak was well resolved from the peaks of the
degradation products. The proposed method was validated
for sensitivity, selectivity, linearity, accuracy,
precision and solution stability. From the degradation
studies it was found that the drug was thermally stable
but unstable in acidic, alkaline, neutral and oxidative
conditions. The response of drug was linear in the
concentration Range of 1 - 50 μg/ml with the number of
theoretical plates, and tailing factor being 1341 and 1,
respectively. Limit of detection and limit of
quantification were 0.1 and 0.2, μg/ml respectively
while recovery ranged from 95 - 100%. Method precision
and precision of the system were within the limits of
acceptance criteria.
Conclusion:
This study presents a simple and validated
stability-indicating HPLC method for the estimation of
cefazolin in the presence of degradation products. The
developed method is specific, accurate, precise and
robust. All the degradation products formed during
forced degradation studies were well separated from the
analyte peak.
Keywords:
Cefazolin; Stability-indicating assay; Reversed-phase
HPLC
