Uv spectrophotometric method development and validation for determination of sultamicillin tosylate in api and in pharmaceutical dosage form

Simple, rapid, sensitive, precise and specific UV Spectrophotometric for the determination of Sultamicillin Tosylate in API and pharmaceutical dosage form were developed and validated. In this method solutions of Sultamicillin Tosylate were prepared in Methanol. Sultamicillin Tosylate standard solution was scanned in the UV range (400-200nm) in a 1cm quartz cell in a double beam UV spectrophotometer. The standard solution of Sultamicillin Tosylate showed maximum absorption at wavelength 232 nm. The method obeys Beer’s law in the concentration range from 20-100µg/ml. The correlation coefficient was found to be 0.999 and regression of the curve was found Y=0.004x+0.052 with excellent recovery 97-102%. Limit of detection and limit of quantification were found to be 3.689µg/ml and 11.18µg/ml respectively. The ruggedness and robustness was performed. The method was validated for several parameters like accuracy, precision as per ICH guidelines. Statistical analysis proved that the methods are repeatable and specific for determination of the said drug. These methods can be adopted in routine assay analysis of Sultamicillin Tosylate in API and pharmaceutical dosage form.