Analysis and validation of pure and synthetic Nizatidine drug by reversed-phase high-performance liquid chromatography

A new reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for estimating Nizatidine in bulk and from in-house synthesis mixtures. The isocratic method uses the mobile phase of a C۸ shim-pack column (۲۵۰ mm×۴.۶, ۵ μm) with acetonitrile and water (۹۰:۱۰). The wavelength was detected and quantified at ۲۴۰ nm with a flow rate of ۱.۱ mL min-۱. Peak elution occurred at ۲.۸۱۶ minutes, with ۳۳۷۳ USP theoretical plates and a tailing factor ۱.۲۰۲. The approach was verified regarding system suitability, linearity, specificity, precision, accuracy, robustness, limit of detection (LOD), and limit of quantification (LOQ). The LOD for nizatidine was ۰.۰۱۱ μg mL-۱, whereas the LOQ was ۰.۰۴۹ μg mL-۱. The linearity range, the percentage RSD, and the correlation coefficient were obtained at ۲ -۱۴ μg mL-۱, ۰.۶۱, and ۰.۹۹۹۳, respectively. The proposed method yielded ۹۹.۳±۰.۴۹ %, ۹۹.۱±۰.۳۲ %, and ۱۰۱.۲±۰.۰۶ % recovery rates for Nizatidine at ۸۰ %, ۱۰۰ % and ۱۲۰ % spiking levels. The percentage assay was calculated, and it was found to be ۱۰۱.۹. The proposed approach was verified according to the ICH Q۲ (R۱) criteria. The approach was accurate, specific, precise, robust, and rugged for estimating Nizatidine in the developed synthetic mixture.

کلیدواژه ها:

nizatidine ، High-performance liquid chromatography ، Analytical Validation ، ICH Q۲ (R۱) ، Environment