Characterization and Pre-formulation studies of Hydrochlorothiazide by using various analytical techniques

Abstract

The compatibility studies deal with the physical; chemical properties of Active ingredient (HTZ) with excipient binary mixture.
The tasks for saturated solutions have carried out over the pH range of 1.2-6.8. The Solubility of Hydrochlorothiazide is about
0.08mg/L in the water at 37°C. 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 PSD histograms represent the presence of Dv (50) 15.8 µm; Dv (90) 98.1 µm particles of Hydrochlorothiazide.
From the p-XRD studies; the diffraction line profiles are 2θ values for diffraction peaks at 9.4979°, 19.0697° conforms to form A
of Hydrochlorothiazide. By the UV-Visible; FTIR; NMR and Mass spectroscopy studies Characterized to Hydrochlorothiazide.
The DSC thermo gram at 268.96°C represents the characteristic melting point of API. The Assay content results of
Hydrochlorothiazide were within 99%-101%. Hydrochlorothiazide contains <0.5% impurities A, B, C, with >99.0%and all other
unknown impurities has not detected in any of the drug substances. The compatibility of binary mixtures of drug and excipients
stored at 40°C ± 2°C/ 75% ± 5% R.H. for one month has assessed and the % results of Assay and impurities from initial period to
after 30th day does not have a significant difference; P< 0.01.