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The purpose of this work is to develop and validate reverse phase Ultra performance liquid chromatography (UPLC) method for the rapid and precise determination of ifetroban sodium in its pure form and in formulations. A simple, specific, accurate, precise isocratic UPLC method for analysis of Ifetroban sodium was developed and validated using a Phenomenex C18 column (50 mm x 3.0 mm, 3µ) as the stationary phase, in conjunction using Triethyl amine buffer: methanol in the proportion of 25:75 with a flow rate of 1.0 mL/min, run time is 3 min and UV detector is used at 235 nm wavelength. The developed UPLC technique was found to be rapid as the retention time was 0.56 minutes for Ifetroban peak to elute. The developed UPLC technique was validated as per the ICH guidelines for specificity, linearity, accuracy, precision, robustness and found to be satisfactory. Linearity was established in the concentration range 100-300 µg/mL with correlation coefficient of 0.998 and the equation obtained is y = 0.635x + 0.639.The percentage recovery is 100.41. The method is rugged and is trouble free and transferable. The study showed that the developed UPLC technique can be used for the estimation of drug purity, stability, solubility and with no interference of pharmaceutical excipients from the active pharmaceutical ingredient. The precision, accuracy, robustness results obtained enables rapid quantification of ifetroban for quantitative analysis.

The purpose of this work is to develop and validate stability, indicating reverse phase High-performance liquid chromatography (HPLC) method for the rapid and precise determination of droxidopa in its pure form and formulations. A simple, fast, accurate and economical way has been developed and validated for the quantification of droxidopa by HPLC technique. The chromato graphic system was equipped with Shimpack columnC18((250x 4.6) mm, 5µ) as stationary phase and UV detector at 220 nm, in conjunction with a mobile phase of phosphate buffer pH 2.0:acetonitrile (60:40,% v/v) at a flow rate of 1.0 mL/min. The developed HPLC technique was found to be rapid as the retention time was 2.2 minutes for droxidopa peak to elute. The method was validated as per the International Conference on Harmonization (ICH) guidelines for specificity linearity, accuracy, precision. The developed method was selective with well-resolved peak. Linearity was observed over the concentration range of 25-150µg/mL for droxidopa. The recovery of Droxidopa was found to be 100.54% - 101.65%. Statistical techniques were employed for the validation of precision, linearity, accuracy, robustness and ruggedness and can be applied for routine analysis. Validation revealed that the developed method was specific, accurate, precise, reliable, robust, reproducible and suitable for the systematic quantitative review.

A simple, rapid, accurate and economical method has been developed for the quantification of droxidopa by UPLC. The chromatographic system was equipped with Phenomenex column C18 (50mm x 3.0mm, 3µ) as stationary phase and UV detector at 235nm, in conjunction with a mobile phase of buffer: methanol (25:75 % v/v ratio) at a flow rate of 1.0mL/min. Linearity was observed over the concentration range of 100-300µg/mL for droxidopa. The droxidopa peak eluted at 0.35 min. The recovery of Droxidopa was found to be 100.17% - 100.63% respectively. Statistical techniques were employed for the validation of precision, linearity, accuracy, robustness and ruggedness and can be applied for routine analysis. Validation revealed that the developed method was specific, accurate, precise, reliable, robust, reproducible and suitable for the routine quantitative analysis.