title: ICH guidance in practice: validated reversed-phase HPLC method for the determination of active mangiferin from extracts of Mangifera indica Linn.
abstract: This study presents the development and validation of a reversed-phase liquid chromatographic method for the determination of mangiferin (MGN) in alcoholic extracts of mangifera indica. A Lichrospher 100 C(18)-ODS (250 x 4.6 mm, 5 microm size) (Merck, Whitehouse Station, NJ) prepacked column and a mobile phase of potassium dihydrogen orthophosphate (0.01M) pH 2.7 +/- 0.2-acetonitrile (15:85, v/v) with the flow rate of 1 mL/min was used. MGN detection was achieved at a wavelength monitored at 254 nm with SPD-M 10A vp PDA detector or SPD 10AD vp UV detector in combination with class LC 10A software. The proposed method was validated as prescribed by International Conference on Harmonization (ICH) with respect to linearity, specificity, accuracy, precision, stability, and quantification. The method validation was realized using alcoholic extracts and raw materials of leaves and barks. All the validation parameters were within the acceptable limits, and the developed analytical method can successfully be applied for MGN determination.
authors.affiliation: Pharmacy Department, Faculty of Technology & Engineering, The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat, India.
authors.forename: Nagaraj
authors.initials: N
authors.lastname: Gowda
authors.forename: Pradeep
authors.initials: P
authors.lastname: Kumar
authors.forename: Surender
authors.initials: S
authors.lastname: Panghal
authors.forename: Mashru
authors.initials: M
authors.lastname: Rajshree
mesh_terms: D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000592:standards*; D056148:Chromatography, Reverse-Phase / Q000379:methods* / Q000592:standards*; D004355:Drug Stability; D017408:Guidelines as Topic; D031022:Mangifera; D010936:Plant Extracts / Q000737:chemistry*; D044004:Xanthones / Q000032:analysis*
chemical_list: C501277:Mangifera indica extract; D010936:Plant Extracts; D044004:Xanthones; C013592:mangiferin