Setyaningsih Dewi, Santoso Yosua Agung, Hartini Yustina Sri, Murti Yosi Bayu, Hinrichs Wouter L J, Patramurti Christine
Faculty of Pharmacy, Sanata Dharma University, Indonesia.
Faculty of Pharmacy, Universitas Gadjah Mada, Indonesia.
Heliyon. 2021 Mar 24;7(3):e06541. doi: 10.1016/j.heliyon.2021.e06541. eCollection 2021 Mar.
Poor bioavailability has been reported as a major challenge in the development of curcumin as a pharmaceutical agent. However, co-administration of curcumin with piperine has been shown to improve curcumin bioavailability. Therefore, to assure product control quality, an analytical method needs to be developed for the determination of curcumin and piperine content in a dosage form formulation. The objective of this study was to develop a simple isocratic reversed-phase HPLC (RP-HPLC) method to simultaneously quantify curcumin and piperine content in solid dispersion based microparticle formulation containing and extracts. The method was validated according to the International Council for Harmonization (ICH) guideline. Chromatographic separation of three curcuminoids and piperine could be achieved using acetonitrile-methanol-water of 65:5:35 %, at a flow rate of 1 mL/min and a wavelength of 353 nm for detection. Resolution (Rs) of 3.57 and 1.68 for piperine and curcumin, respectively, a theoretical plate number (N) > 8000 and a tailing factor (T) < 1.5 indicate a satisfactory separation of the compounds. The calibration curve was linear from 1.25-15 μg/mL and 2.5-30 μg/mL for piperine and curcumin, respectively, with the correlation coefficient of >0.999. The intra-day/inter-day accuracy and precision demonstrated a recovery of 99.54-101.50%/99.38-99.89% and 100.78-102.51%/101.15-102.47% with a Relative Standard Deviation (RSD) of 0.53-0.95%/0.13-1.44 % and 0.28-1.62%/0.46-1.14% for piperine/curcumin. The limit of detection (LOD) were 0.27 and 0.42 μg/mL, for piperine and curcumin, which reveals an adequate sensitivity. A solid dispersion based microparticle formulation containing and extracts confirmed the validity of the developed method as a recovery of 91.14% and 99.14% for piperine and curcumin, respectively. In conclusion, all the tested parameters confirm the precision, accuracy, and reliability of the method for the simultaneous analysis of curcumin and piperine within a microparticle formulation containing and extracts.
据报道，生物利用度低是姜黄素作为药物制剂开发中的一个主要挑战。然而，已证明姜黄素与胡椒碱共同给药可提高姜黄素的生物利用度。因此，为确保产品质量控制，需要开发一种分析方法来测定剂型制剂中姜黄素和胡椒碱的含量。本研究的目的是开发一种简单的等度反相高效液相色谱（RP - HPLC）方法，以同时定量含有[具体提取物1]和[具体提取物2]提取物的固体分散体基微粒制剂中姜黄素和胡椒碱的含量。该方法根据国际协调理事会（ICH）指南进行了验证。使用体积比为65:5:35%的乙腈 - 甲醇 - 水，流速为1 mL/min，检测波长为353 nm，可实现三种姜黄素类化合物和胡椒碱的色谱分离。胡椒碱和姜黄素的分离度（Rs）分别为3.57和1.68，理论塔板数（N）> 8000且拖尾因子（T）< 1.5，表明化合物分离良好。胡椒碱和姜黄素的校准曲线分别在1.25 - 15 μg/mL和2.5 - 30 μg/mL范围内呈线性，相关系数> 0.999。日内/日间准确度和精密度表明，胡椒碱/姜黄素的回收率分别为99.54 - 101.50%/99.38 - 99.89%和100.78 - 102.51%/101.15 - 102.47%，相对标准偏差（RSD）分别为0.53 - 0.95%/0.13 - 1.44%和0.28 - 1.62%/0.46 - 1.14%。胡椒碱和姜黄素的检测限（LOD）分别为0.27和0.42 μg/mL，显示出足够的灵敏度。含有[具体提取物1]和[具体提取物2]提取物的固体分散体基微粒制剂证实了所开发方法的有效性，胡椒碱和姜黄素的回收率分别为91.14%和99.14%。总之，所有测试参数均证实了该方法在含有[具体提取物1]和[具体提取物2]提取物的微粒制剂中同时分析姜黄素和胡椒碱的精密度、准确度和可靠性。
