Objective: The present study was aimed to develop a rapid, specific and sensitive method based on high performance liquid chromatographic method was developed for the determination of telmisartan using indapamide as an internal standard.Methods: The utilization of single step protein precipitation method using methanol as a precipitating agent becomes suitable for analysis of a large number of samples. The developed method was validated as per US-FDA guidelines for telmisartan in human plasma.Result: An isocratic separation was achieved using Hibar C18 (250 x 4.6 mm, 5 μm) column using 10 mmol ammonium formate solution (pH 4.0)–methanol (70:30, v/v) as the mobile phase. Detection was carried out at 275 nm. The method was validated over the range of 0.1–1.5 µg/ml in human plasma with a regression analysis of 0.996. The percentage recovery of the present method was found to be 94.0–99.2 %.Conclusion: The developed analytical method was found to be rapid, single step, plasma preparation coupled with the simple high-performance liquid chromatography coupled with UV detection (HPLC–UV) isocratic chromatographic apparatus makes the method cost-effective and suitable for analysis of a large number of samples.
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.
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