Ramadan Hesham Sameh, Belal Fathalla, Roshdy Aya, Salim Mohamed M
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Suez Canal University, Ismailia, Egypt.
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Horus University- Egypt, New Damietta, Egypt.
Sci Rep. 2025 Apr 15;15(1):12922. doi: 10.1038/s41598-025-95706-3.
A reversed phase HPLC method with UV detection was designed for the first time for the simultaneous estimation of meloxicam and esomeprazole in their combined tablet dosage forms. Full factorial design was used for rapid optimization of the proposed method. Chromatographic separation was reached using isocratic elution on C18 column. The mobile phase was a mixture of methanol: acetonitrile: 0.05 M potassium dihydrogen phosphate buffer at pH 5, adjusted using phosphoric acid and/or NaOH when needed. The flow rate was 1 mL/min and the injection volume was 20 µL. The detection wavelength was 230 nm. The working ranges of the method were 5.0-100.0 and 10.0-100.0 µg/mL, LOD values were 0.8 and 1.8 µg/mL and LOQ values were 2.6 and 5.5 µg/mL for meloxicam and esomeprazole, respectively. The proposed method was successfully applied to their combined tablet dosage forms with acceptable % recoveries (100.4 - 100.7%) obtained. Four methods were used to evaluate the greenness of the proposed method, suggesting the acceptability of the greenness of the proposed method.
首次设计了一种带紫外检测的反相高效液相色谱法,用于同时测定美洛昔康和埃索美拉唑复方片剂剂型中的含量。采用全因子设计对所提出的方法进行快速优化。在C18柱上采用等度洗脱进行色谱分离。流动相为甲醇:乙腈:pH 5的0.05 M磷酸二氢钾缓冲液的混合物,必要时用磷酸和/或氢氧化钠调节。流速为1 mL/min,进样体积为20 μL。检测波长为230 nm。该方法对美洛昔康和埃索美拉唑的工作范围分别为5.0 - 100.0和10.0 - 100.0 μg/mL,检测限分别为0.8和1.8 μg/mL,定量限分别为2.6和5.5 μg/mL。所提出的方法成功应用于其复方片剂剂型,回收率在可接受范围内(100.4 - 100.7%)。采用四种方法评估所提出方法的绿色度,表明该方法的绿色度是可接受的。