A comparative analytical determination of phenylphrene and cephalexin in pure and pharmaceutical preparations

Hussein, Nada Gaaeb and Hussein, Manal Mahmoud and Hussein, Huda Gaaeb and Saeed, Ahmed Mahdi (2025) A comparative analytical determination of phenylphrene and cephalexin in pure and pharmaceutical preparations. GSC Biological and Pharmaceutical Sciences, 31 (3). pp. 230-237. ISSN 2581-3250

Validation of analytical methods is an important role in analytical analysis. In this research, an accurate, efficient and reproducible isocratic reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for the estimation of phenylephrine hydrochloride (PHP) and cephalexin (CPH). A mixture of drugs as standard material and in formulation tablets were separated using a phenomenex C18 column, (L, 15 cm, 0.46 cm, I.D, and 5 μm Size of particle), with the Shimadzu HPLC, model LC–20 - A, Japan. The eluent phase was optimized through the design, experiment. Elution was done by an eluent phase composed of water (H2O), methanol (MOH) and acetonitrile (ACN) mixture have a ratio of (60: 20: 20, V/V), with adjusted pH of 3.0 with acetic acid, have a pumped flow rate of 1.0 mL/min. The drugs, separation were performed at 270 nm using a UV-VIS - detector for 10 min. The time of elution for the drugs was recorded at (3.685 and 6.134 min) for PHP and CPH respectively. The validation of the method was conducted in a range of concentration (1 - 60 µg/mL) for PHP and CPH. The method was found to be robust, specified and resisting against the small experimental changes in the value of the flow rate, pH, and wavelength. The LOD was found to be 0.5 µg/mL for PHP and CPH. The values of LOQ were 1.65µg/ for PHP and CPH.