Method Development And Validation of Sultamcillin Tosylate in Tablet Dosage form by RP-HPLC and HPTLC

AIM: To develop and validate a new isocratic RP-HPLC and HPTLC methods for the determination of sultamcillin tosylate in tablet dosage form. To validate the method with respect to linearity, precision, accuracy and robustness. To develop the method suitable for routine analysis of sultamcillin tosylate in pharmaceutical formulation. OBJECTIVE : The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. PLAN OF WORK: Solubility data,analytical data is to be studied to develop the initial conditions. Selection of initial separation conditions and trails for assay of sultamcillin tosylate in pharmaceutical dosage form. To develop a method for the assay of sultamcillin tosylate in pure and marketed sample by RP-HPLC and HPTLC. To validate the developed assay method according to ICH method validation parameters such as system suitability, linearity, precision, accuracy, robustness,etc CONCLUSION: A RP-HPLC method was developed for the estimation of Sultamcillintosilate in a tablet dosage form utilizing HPLC SHIMADZU 2010 PROMINENCE -separation module withUV-VIS detector kromasilC18 3.5μ(100mm×4.6mm) Injection volume of 10 μl is injected and eluted with the mobile phase of buffer and Acetonitrile in the ratio of 80:20 which is pumped at the flow rate of 1.0ml/min and detected at 215 nm wavelength using uv-vis detector. The run time per sample is 20 min. The peaks for Sultamcillin tosilate were found at 9.05. The excipients in the formulation did not interfere in the accurate estimation of Sultamcillin tosilate. The developed method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with International Conference on Harmonization guidelines .The proposed method is applied for determination for Sultamcillin tosilate new formulation. Since none of the methods is reported estimation of Sultamcillin tosilate in oral dosage form, this developed method can be used for routine analysis of component in formulation. A simple, and selective high performance thin layer chromatographic method was developed and validated for estimation of Sultamcillin tosilate pharmaceutical dosage forms. The method employed precoated TLC aluminum plates with silica gel 60F254 as the stationary phase. The solvent system comprised Acetonitrile: Methanol:Water(3.5:5:1.5 v/v/v). The retention factor is 0.65min for sultamcillin tosilate. Spectrodensitometric scanning integration was performed 215 nm. The polynomial regression data for the calibration graph showed good linear relationship with R2 = 0.9963 in the concentration range of 1-6 μg/spot. The developed method was validated for precision and recovery. The proposed method is applied for determination for sultamcillintosilate