Regulatory Based Method equivalency study to Estimate the Terbutaline sulfate API by RP-HPLC method
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A novel, regulatory based HPLC method has been developed and validated for the estimation of Terbutaline sulphate API. Column is X- bridge shield RP-18 150×4.6 mm, 3.5 µm, wave length 223 nm, injection volume 15 µL, column temperature is 30°C,sampler temperature 5°C and flow rate 0.8 mL/min. Retention time of terbutaline sulfate is about 7.226 minutes and Runtime 10 minutes. The developed methods have been validated as per ICH guidelines. The method exhibited satisfactory with precision, specificity, linearity, robustness and ruggedness. The proposed method was found to be equivalent to USP method.
