Open AccessAssessment of suitability of saxagliptin hydrochloride for development of controlled release parenteral formulation by preformulation studies
Author(s) -
Chirag Karshanbhai Patel,
Disha Suthar,
Hetal Patel,
Vinit Movaliya,
Punit B. Parejiya
Publication year - 2022
Publication title -
international journal of health sciences (ijhs) (en línea)
Language(s) - English
Resource type - Journals
eISSN - 2550-6978
pISSN - 2550-696X
DOI - 10.53730/ijhs.v6ns3.6336
Subject(s) - saxagliptin , differential scanning calorimetry , high performance liquid chromatography , chromatography , active ingredient , fourier transform infrared spectroscopy , chemistry , dosage form , materials science , pharmacology , medicine , diabetes mellitus , chemical engineering , type 2 diabetes mellitus , sitagliptin , physics , endocrinology , engineering , thermodynamics
The main objective of pre-formulation study is to develop the stable, elegant, safe and effective drug delivery system by establishing drug kinetic profile, formulation compatibility with different excipients and physico-chemical parameters of new drug molecules. This could provide key evidence for implementing formulation design or requirement of the molecular alteration. So, in the present study preformulation studies were performed on Saxagliptin Hydrochloride (SXG) to assess its suitability for parenteral formulation. SXG is a potent and selective reversible inhibitor of dipeptidyl peptidase-4 used to treat type –II diabetes mellitus. The authenticity of SXG was established by differential scanning calorimetry (DSC) and fourier transform infrared spectroscopy(FTIR) spectra. An ultraviolet–visible (UV) spectrophotometric and high performance liquid chromatography (HPLC) methods were employed for determination of SXG in bulk API (active pharmaceutical ingredient). The UV method was linear within the range of 1-40 μg/ml. The proposed methodology is robust which can be concluded from the lower percentage standard deviation percentage co efficient of variance (% CV) values of intraday and inter day variability. The retention time was observed 1.3 min of SXG in HPLC method. The higher regression coefficient value (0.999) indicates the methodology is robust.