DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR ESTIMATION OF TELMISARTAN IN HUMAN PLASMA
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 Î¼m) column using 10 mmol ammonium formate solution (pH 4.0)â€“methanol (70:30, v/v) as the mobile phase. Detection was carried out at 275 nm. The method was validated over the range of 0.1â€“1.5 Âµg/ml in human plasma with a regression analysis of 0.996. The percentage recovery of the present method was found to be 94.0â€“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 (HPLCâ€“UV) isocratic chromatographic apparatus makes the method cost-effective and suitable for analysis of a large number of samples.
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