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 concentration and less sensitive methods of analysis such as spectrophotometry may be useful for its quantification. The aim is to develop 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 increasing the рН value 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 developed using the mentioned solvents and wavelengths respectively. Their validation by such parameters as stability, linearity, accuracy and precision in the variants of the method of calibration curve and method of standard has been carried out. The procedures A, B and D of secnidazole quantitative determination are acceptable for application. The best linearity, accuracy and repeatability have been fixed for the procedure D in the variant of the method of calibration curve.