title: UV derivative spectrophotometric and RP-HPLC methods for determination of imidapril hydrochloride in tablets and for its stability assessment in solid state.
abstract: Two methods for determination of imidapril hydrochloride (IMD) in the form of tablets were developed and the stability-indicative determination of IMD in solid state formulations by means of the proposed methods was investigated. IMD is not a pharmacopeial raw material, therefore there is no official method for its determination and purity assessment. The following analytical techniques were adopted for IMD determination: reverse-phase high performance liquid chromatography (RP-HPLC) and first derivative (1D) ultraviolet spectrophotometry. RP-HPLC analysis was performed with the use of LiChrosfer RP-18 column as a stationary phase and acetonitrile-methanol-phosphate buffer pH 2.0 (60:10:30 v/v/v) as a mobile phase. The proposed method showed good linearity (in a range 40.0 - 400.0 microg/mL), accuracy, precision and selectivity for: IMD, its degradation product, and for oxymetazoline as an internal standard (IS). Additionally, different spectrophotometric methods were tested, and the first derivative spectrophotometry was accepted for further research. This method showed good linearity (in a range 4.0 - 40.0 microg/mL), precision and accuracy. The proposed methods were successfully applied to the pharmaceutical dosage form containing the investigated compound without any interference from the excipients. Finally, the results of the suggested methods were statistically compared using t-Student and F-Snedecor tests in the assessment for their equivalence.
authors.affiliation: Department of Pharmaceutical Chemistry, University of Medical Science, 6 Grunwaldzka St., 60-780 Poznań, Poland. bstanisz@ump.edu.pl
authors.forename: Beata
authors.initials: B
authors.lastname: Stanisz
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Regulska
authors.forename: Kinga
authors.initials: K
authors.lastname: Kolasa
mesh_terms: D000806:Angiotensin-Converting Enzyme Inhibitors / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006813:Humidity; D006863:Hydrogen-Ion Concentration; D048289:Imidazolidines / Q000032:analysis*; D007700:Kinetics; D015203:Reproducibility of Results; D012995:Solubility; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets; D013696:Temperature
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D048289:Imidazolidines; D012996:Solutions; D013607:Tablets; C065166:imidapril