QbD Assisted RP-HPLC Method for Identification of Terazosin in Bulk Drug and Pharmaceutical Sample

Reversed Phase High Performance Liquid Chromatographic (RP-HPLC) proves to be a convenient and reliable technique for the identification of various compounds, such as pharmaceutical drugs of chemical as well as phyto origin, food compounds and others. Analytical method for the estimation of alpha-1 antagonist terazosin, a potent anti-hypertensive agent for enlarged prostate, was developed, optimized for the best fit condition using statistical software Minitab and validated as per International Conference on Harmonization (ICH) Q2 (R1) guidelines. Partitioning of the desired molecule was achieved on Agilent Zorbax C18 column with dimensions of 250 mm X 4.6 mm and a particle size 5μm against mobile phase containing acetate buffer adjusted to pH 6.0 and acetonitrile (ACN) in a ratio 30:70 (V/V), run isocratically for sufficient time. The linear model was established between 50 – 250 ppm with a regression coefficient (r2) of 0.9971 and with detection (LOD) and quantification limit (LOQ) of 17.754 ppm and 53.802 ppm, respectively. The method was precise, accurate, robust and able to distinguish between the adduct generated during forced degradation studies.