Characterization and Compatibility studies of Enalapril maleate by using various analytical techniques
DOI:
https://doi.org/10.61096/ijpar.v10.iss2.2021.237-249Keywords:
Compatibility studies, DSC, NMR, FTIR, p-XRD, Enalapril maleate, solubility.Abstract
Objective: The study aimed to analyse and evaluate the physical; chemical properties of enalapril maleate by using various analytical methods.
Methods: Preliminarily, the active ingredient was admixed with Corn Starch; CMC Sodium; MCC, Crospovidone; PVP K-30; SSG; Magnesium Stearate; and DCP in a dose proportionate and carried the solubility studies; particle size (PSD); crystal characteristics (p-XRD); purity by thermogram (DSC); Assay and related substance by HPLC.
Results: The solubility of the active ingredient is 885.4mg/L in water. Further, the solubility is not affected significantly (P<
0.05) in the buffer solutions in a pH range of 1.2 to 6.8. The presence of Dv (50) 22.4 µm; Dv (90) 95.9 µm particles in the solid powder form of the drug substance. The 2θ values for diffraction peaks at 15.6199°, 20.4798°, 20.8780°conforms to form C of the drug substance. By the UV-Visible; FTIR; NMR and Mass spectroscopy studies characterized the drug. The endothermic peak at
152.04°C conforms to drug melting point. The % Assay content result has occurred in between 99.0%+0.8% to 99.5%+0.5(n=3). The drug contains 0.02+0.005% to 0.08+0.004 of impurity A, 0.12+0.001 to0.18+0.003 of impurities B, 0.09+0.003 to 0.16+0.006 C, 0.12+0.002 to 0.23+0.002 D with purity >99.95%, and all other unknown related substance has <0.01% of below detection
Limit.
Conclusion: The compatibility of binary mixtures of drug and excipient were assessed, and concluded, the API does not have any incompatibility with listed excipients.
