Determination of Residual Protein in Amoxicillin Capsules Through Enzymatic Process by HPLC

WANG Bingling; ZHANG Hao; GENG Lele; FENG Yurong

doi:10.13748/j.cnki.issn1007-7693.20231946

WANG Bingling, ZHANG Hao, GENG Lele, FENG Yurong. Determination of Residual Protein in Amoxicillin Capsules Through Enzymatic Process by HPLC[J]. Chinese Journal of Modern Applied Pharmacy, 2025, 42(6): 984-988. DOI: 10.13748/j.cnki.issn1007-7693.20231946

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Determination of Residual Protein in Amoxicillin Capsules Through Enzymatic Process by HPLC

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OBJECTIVE To determine the residual penicillin G acylace(PGA) in Amoxicillin capsules by HPLC.
METHODS Bradford method combined with HPLC was used for the quantitative analysis of PGA. Using PGA as the standard, the sample solution was separated by reverse phase chromatography column with polymer matrix, detected by fluorescence detector, and quantified by external standard method.
RESULTS The linear range of PGA was 0.15−1.50 μg·mL⁻¹(r=0.9986). The limits of detection and quantiation were 1.5 mg·kg⁻¹ and 3.0 mg·kg⁻¹. The average recoveries for the target compound were >80%. PGA was basically stable within 24 h in the sample solution of Amoxicillin capsule contents.
CONCLUSION This method is simple, specific, and demonstrates high recovery and reproducibility, making it suitable for determining PGA residues in enzymatically produced Amoxicillin capsules‌.

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Determination of Residual Protein in Amoxicillin Capsules Through Enzymatic Process by HPLC

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