Validated Stability Indicating Spectrophotometric Method for Estimation of Degradation Behavior of Pyrimethamine and Sulphadoxine in Tablet Formulation
Raghunath D. Wadulkar1*, T. M. Kalyankar2, O. A. Khogre2, K. Anitha3
A new, simple, rapid and novel stability indicating spectrophotometric method has been developed and validated for estimation of degradation behavior of pyrimethamine and sulphadoxine in tablet formulation. For this, first order derivative method is used. The method involved measurement of absorbance at two wavelengths 273.8 nm and 262.5 nm of pyrimethamine and sulphadoxine respectively. This method obeys Beer’s law in the employed concentration ranges of 1-6 μg/ml and 4-24 μg/ml for pyrimethamine and sulphadoxine respectively. Beer's law was obeyed in this concentration range with correlation coefficient of 0.997 and 0.998 for pyrimethamine and sulphadoxine respectively. The accuracy and precision of the method were determined and validated according to ICH guidelines. The method has good reproducibility with percent relative standard deviation (% RSD) less than two. The proposed method was validated for accuracy, precision, linearity, limits of detection (LOD), quantitation (LOQ) and reproducibility. The observations were found within the limits, stability study was performed for both drugs by using acid, base, neutral hydrolysis, oxidation, thermal and photolytic degradations which indicate the stability indicating property of the method. The proposed method is recommended for routine analysis work since it is rapid, simple, accurate, specific and sensitive.
Share this article