Abstract
Objective:To establish a RP-HPLC method for determination of the lincomycin hydrochloride content in lincomycin hydrochloride thermosensitive eye gel.Methods:The separation was performed on a Diamond C18 column(250 mm×4.6 mm,5 μm) with the mobile phase consisting of 0.05 mol/L borax water solution(pH value adjusted to 7.4 by phosphoric acid)-methanol(50∶50) at the flow rate of 1.0 ml/min.The detection wavelength was 214 nm.Results:Lincomycin hydrochloride presented a good linearity within the range of 2-48 μg/ml(r=0.999 9).It had good intra-and inter-day precision,stability and reproducibility.The average recovery rates of low,middle and high concentrations(11.608,17.584,41.501 μg/ml) were(91.40±1.27)%,(97.55±0.93)% and(99.13±1.11)%(n=3),respectively.The average contents of lincomycin hydrochloride in three batches of samples were(98.67±1.21)%,(99.90±0.44)% and(99.28±1.17)%(n=3),respectively.Conclusion:It is an accurate,sensitive and reproducible method for determination of the lincomycin hydrochloride content in lincomycin hydrochloride thermosensitive eye gel.
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