目的 建立格列喹酮片體外溶出度HPLC檢測(cè)方法及溶出曲線評(píng)價(jià)。方法 色譜柱為Diamonsil@Plus C₁₈（150 mm×4.6 mm，5 μm）；流動(dòng)相為磷酸二氫銨溶液（取磷酸二氫銨1.725 g，加水300 mL溶解后，用磷酸調(diào)節(jié)pH值至3.5±0.1）-乙腈（3：5）；體積流量1.0 mL/min；檢測(cè)波長(zhǎng)為310 nm，進(jìn)樣量20 μL，柱溫為35℃，外標(biāo)法計(jì)算。結(jié)果 空白輔料、溶出介質(zhì)不干擾測(cè)定；格列喹酮在3.13~50.02 μg/mL線性關(guān)系良好（r=0.999 8，n=7）；格列喹酮平均回收率為100.2%（RSD=0.83%，n=9）；格列喹酮溶出度溶液在0~24 h內(nèi)穩(wěn)定性良好（RSD=0.51%，n=7）；棄去10 mL初濾液后濾膜吸附達(dá)到飽和。自研品和參比制劑在7種不同pH溶出介質(zhì)中溶出行為一致。結(jié)論 經(jīng)方法學(xué)考察，反相高效液相色譜法測(cè)定格列喹酮片溶出度專(zhuān)屬性強(qiáng)，準(zhǔn)確可靠，易于操作。

Objective To develop a HPLC method for determinating the dissolution of gliquidone tablet in vitro and evaluate the dissolution profiles.Methods The chromatographic conditions included Colum Diamonsil@Plus C₁₈ (150 mm×4.6 mm,5 μm) and 0.05 mol/L NH₄H₂PO₄ (adjusted to pH 3.5 ±0.1 with diluted phosphoric acid) -acetonitrile (3:5) as the mobile phase, at a flow rate of 1.0 mL/min, detected at 310 nm, injection volum was 20 μL, the column temperature was 35℃, using external standard method to calculate.Results gliquidone could be determined really, blank excipients and dissolution media were uninfluenced for determination. There was a good linearity in the range of 3.13-50.02 μg/mL (r=0.999 8, n=7), the average recovery of gliquidone was 100.2% (RSD=0.83%, n=9). Through 48 h stability test, the solution of gliquidone was good. The adsorption of the filter membrane reached saturation after abandoning 10 mL initial filtrate. The self-prepared formulation and reference preparation are consistent dissolution behavior in different seven media.Conclusion The established method is high selective, simple and accurate. The method can be used for the determination of dissolution for gliquidone tablets.