title: A validated stability-indicating HPLC method for the determination of PEGylated puerarin in aqueous solutions.
abstract: The aim of this study was to develop a validated specific stability-indicating HPLC method for the quantitative determination of PEGylated puerarin (PEG-PUE) in aqueous solutions. The method was validated by subjecting PEG-PUE to forced degradation under stress conditions of acid, alkali, water hydrolysis, and oxidation. Both PEG-PUE and puerarin (PUE) were simultaneously determined and separated on CAPCELL PAK C18 column by gradient elution with 0.2% aqueous phosphoric acid and acetonitrile as the mobile phase. The flow rate was 1.0 mL min(-1) and detection wavelength was set at 250 nm. Both calibration curves showed good linear regression (r> or =0.9998) within test ranges. The LOD and LOQ of PEG-PUE were determined to be 3 and 9 microg mL(-1) respectively. Degradation of PEG-PUE followed pseudo-first-order kinetics with t(1/2) of 59 min at pH 9.0 and 17.79 h at pH 7.4. However, at pH 5.0 and 2.0, there was no significant degradation of PEG-PUE over time. In conclusion, the method was observed to have the necessary specificity, precision, and accuracy, and to be suitable for quantity monitoring the degradation process of PEG-PUE during stability studies. The degradation studies may give insight into useful information for formulation development of PEG-PUE.
authors.affiliation: Department of Chinese Medicinal Prescription, China Pharmaceutical University, Nanjing 2111198, China.
authors.forename: Xinyi
authors.initials: X
authors.lastname: Liu
authors.forename: Boyang
authors.initials: B
authors.lastname: Yu
authors.forename: Naijie
authors.initials: N
authors.lastname: Wang
authors.forename: Bei
authors.initials: B
authors.lastname: Zhang
authors.forename: Feng
authors.initials: F
authors.lastname: Du
authors.forename: Cheng
authors.initials: C
authors.lastname: He
authors.forename: Zuguang
authors.initials: Z
authors.lastname: Ye
mesh_terms: D000143:Acids / Q000737:chemistry; D000468:Alkalies / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007529:Isoflavones / Q000032:analysis* / Q000737:chemistry; D007700:Kinetics; D057230:Limit of Detection; D010084:Oxidation-Reduction; D011092:Polyethylene Glycols / Q000032:analysis* / Q000737:chemistry; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D013997:Time Factors; D014867:Water / Q000737:chemistry
chemical_list: D000143:Acids; D000468:Alkalies; D007529:Isoflavones; D012996:Solutions; D014867:Water; D011092:Polyethylene Glycols; C033607:puerarin