Development and validation of UV-spectrophotometric procedures for secnidazole quantitative determination

Abstract

Secnidazole is one of the antiprotozoal medicines from the group of 5-nitroimidazoles, which is characterized by a prolonged serum half-life. For secnidazole determination the method of HPLC is widely used, but secnidazole is applied in high concen-tration and less sensitive methods of analysis such as spectrophotometry may be useful for its quantification. The aim is to de-velop a number of UV-spectrophotometric procedures of secnidazole quantification and carry out step-by-step validation of the developed procedures. UV-spectra of secnidazole in 0.1 M hydrochloric acid solution (A), 96% ethanol (B), 0.1 M potassium hydroxide solution in methanol (C), 0.1 M sodium hydroxide solution (D) have been investigated and it has been set that when in-creasing the рНvalue step-by-step shift of substance maximum absorption to the right is observed (277 nm →310 nm →314 nm →319 nm). The procedures of secnidazole quantitative determination by the method of UV-spectrophotometry have been devel-oped using the mentioned solvents and wavelengths respectively. Their validation by such parameters as stability, linearity, accu-racy and precision in the variants of the method of calibration curve and method of standard has been carried out. The proce-dures A, B and D of secnidazole quantitative determination are acceptable for application. The best linearity, accuracy and re-peatability have been fixed for the procedure D in the variant of the method of calibration curve.