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[摘要]
目的 建立瑞巴派特片體外溶出度HPLC檢測方法及方法學(xué)驗證。方法 溶出度試驗采用槳法,轉(zhuǎn)速50 r/min;以水、pH 1.2鹽酸(含氯化鈉)、pH6.0枸櫞酸-磷酸二氫鈉緩沖液和pH6.8磷酸緩沖液為溶出介質(zhì),HPLC法測定溶出量。結(jié)果 瑞巴派特在5.533~221.334 μg/mL內(nèi)線性關(guān)系良好(r=0.999 9),專屬性、精密度、準(zhǔn)確度、溶液穩(wěn)定性及耐用性等均良好。結(jié)論 本方法簡單方便,提高了瑞巴派特溶出度測定的專屬性和準(zhǔn)確性,可用于該制劑的質(zhì)量控制。
[Key word]
[Abstract]
Objective To establish and evaluate a method for determining the dissolution of Rebamipide Tablets in vitro.Methods The paddle method was used for the dissolution test and the rotation rate was set at 50 r/min. Useing water,pH 1.2 hydrochloric acid solution (containing sodium chloride), pH 6.0 Citrate-sodium dihydrogen phosphate buffer solution and pH 6.8 phosphate buffer solution as dissolution media. HPLC was used for the determination of dissolution quantity.Results There was a good linear relationship between the quality concentration of Rebamipide and peak area in the range of 5.533-221.334 μg/mL (r=0.999 9). Specificity, precision, accuracy, solution stability and durability were all good.Conclusion The HPLC method is simple,which improve the specificity and accuracy of dissolution determination for rebamipide tablets, and it can be used for the quality control of the preparation.
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