Cefdinir is
a semi-synthetic oral antibiotic belonging to the cephalosporin family of
antibiotics. For the estimation of the drug Cefdinir, several methods are
available in the literature. The aim of this study was to develop a faster
method for eluting Cefdinir. The present work involves a rapid and reproducible
HPLC method, which was developed and comprehensively validated for the
estimation of the drug cefdinir in the bulk drug and pharmaceutical dosage
forms. Tinidazole was used as an internal standard. The method addresses
challenges such as long run times, unstable retention behaviour, and inadequate
resolution. Chromatographic separation was achieved using a C18 column under
isocratic conditions with a mobile phase tailored for optimal peak shape and
robustness. Validation followed ICH Q2(R1) guidelines, demonstrating excellent
linearity (r² ≥ 0.999), precision (%RSD ≤ 2%), and accuracy (98–102% recovery).
The method further exhibited strong ruggedness and robustness under deliberate
variations. These results confirm the suitability of the developed method for
routine quality-control applications. The validated method was successfully
applied to the commercially available pharmaceutical dosage forms.
Author(s) Details
Gadapa Nirupa
Department of
Chemistry, Jawaharlal Nehru Technological University, Kukatpally, Hyderabad,
A.P 500085, India.
Upendra M. Tripathi
R and D Department,
Startech Labs Pvt. Ltd., 2nd Floor, S M R Chambers, H. No 1-58/7 Madinaguda,
Hyderabad, A.P, 500050, India.
Please see
the book here :- https://doi.org/10.9734/bpi/cbrp/v8/6752
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