DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR CEFPROZIL ESTIMATION
DOI:
https://doi.org/10.22159/ijcpr.2025v17i4.7027Keywords:
HPTLC, Cefprozil, Validation, Pharmaceutical analysis, Quality controlAbstract
Objective: To develop and validate a precise, robust, and efficient High-Performance Thin Layer Chromatography (HPTLC) method for quantitatively estimating Cefprozil in bulk and pharmaceutical tablet formulations.
Methods: HPTLC analysis was performed using silica gel 60 F254 plates and a mobile phase of methanol, ethyl acetate, and triethylamine (5.5:4.5:0.2 v/v/v). Densitometric detection was conducted at 285 nm. The method was validated as per ICH guidelines.
Results: Cefprozil exhibited an Rf value of 0.48. The method showed good linearity in the 2-10 µg/band range with a correlation coefficient (R²) of 0.9989. The LOD and LOQ were found to be 0.5227 µg and 1.5840 µg per band, respectively. Recovery ranged between 98 %-102%, indicating accuracy. Robustness and specificity studies confirmed the method’s reliability under slight variations.
Conclusion: The developed HPTLC method is simple, specific, reproducible, and suitable for the routine quality control of Cefprozil in pharmaceutical formulations.
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