title: A novel quantification method of pantaprazole sodium monohydrate in sesquihydrate by thermogravimetric analyzer.
abstract: To demonstrate the applicability of thermogravimetric analyzer as a tool for the quantification of pantaprazole sodium monohydrate in sesquihydrate, studies have been conducted. Thermal analysis (DSC, TGA) crystallographic (PXRD) and spectroscopic techniques (FT-IR) were used for the characterization of the polymorphs. Thermogravimetric analysis (TGA) analysis was explored by high-resolution dynamic (Hi-Res-dynamic) and high-resolution modulated (Hi-Res-modulated) test procedures to quantify the hydrate polymorphic mixtures. The two polymorphic forms exhibited significant differences and good resolution in the second derivative thermogram generated by Hi-Res-modulated test procedure. Thus, the TGA with Hi-Res-modulated test procedure was considered for the quantification of monohydrate in sesquihydrate. The calibration plot was constructed from the known mixtures of two polymorphs by plotting the peak area of the second derivative thermogram against the weight percent of monohydrate. Using this novel approach, 1 wt% limit of detection (LOD) was achieved. The polymorphic purity results, obtained by TGA in Hi-Res-modulated test procedure were found to be in good agreement with the results predicted by FT-IR and was comparable with the actual values of the known polymorphic mixtures. The Hi-Res-modulated TGA technique is very simple and easy to perform the analysis.
authors.affiliation: Department of Analytical Research and Development, IPD, Dr. Reddy's Laboratories Ltd., Unit-III, Plot No. 116, S.V. Co-Op. Ind. Estate, Bollaram, Jinnaram, Medak Dist 502325, Andhra Pradesh, India.
authors.forename: V Ranga
authors.initials: VR
authors.lastname: Reddy
authors.forename: M Anantha
authors.initials: MA
authors.lastname: Rajmohan
authors.forename: R Laxmi
authors.initials: RL
authors.lastname: Shilpa
authors.forename: Dilip M
authors.initials: DM
authors.lastname: Raut
authors.forename: Kolla
authors.initials: K
authors.lastname: Naveenkumar
authors.forename: M V
authors.initials: MV
authors.lastname: Suryanarayana
authors.forename: Vijayavitthal T
authors.initials: VT
authors.lastname: Mathad
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000032:analysis*; D000897:Anti-Ulcer Agents / Q000032:analysis*; D002138:Calibration; D002152:Calorimetry, Differential Scanning; D000077402:Pantoprazole; D011208:Powders; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D017550:Spectroscopy, Fourier Transform Infrared; D013818:Thermogravimetry / Q000379:methods*; D014867:Water / Q000737:chemistry*; D014961:X-Ray Diffraction
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D011208:Powders; D014867:Water; D000077402:Pantoprazole