DEVELOPMENT OF A SIMPLE UV-SPECTROPHOTOMETRIC ASSAY METHOD FOR SATRANIDAZOLE AND STUDY OF ITS DEGRADATION PROFILE

Abstract

A simple, selective, rapid, precise, economical, reproducible and stability-indicating UV spectrophotometric method has been developed and validated for determination of Satranidazole in pure form and pharmaceutical dosage form. From solvent effect studies and the spectral behaviour of Satranidazole, methanol was selected as solvent. The UV spectrum was scanned between 200 to 400 nm and 318 nm was selected as maximum wavelength for absorption. Beer’s law was obeyed in the concentration range of 2-30 µg /mL. The regression coefficient was 0.999. The method was validated for accuracy, precision, specificity and robustness, in accordance with ICH guidelines. Recovery studies gave satisfactory results indicating that none of common additives and excipients or the degraded impurities interfere in the assay method. Statistical analysis proved the method was precise, reproducible, selective, specific, and accurate for analysis of Satranidazole. Stability testing study includes the effect of oxidation, photolysis and susceptibility to hydrolysis across a wide range of pH values. The wide linearity range, accuracy and easy preparation of diluent imply the method is suitable for routine quantification of Satranidazole in the quality control of bulk forms and pharmaceutical dosage forms with high precision and accuracy.