Optimized and Validated Stability Indicating RP-HPLC Method for the Determination of Telmisartan in Bulk and Pharmaceutical Formulations

Author(s): Jonnala P. Srinivasa Reddy*, T. Vijaya Bhaskara Reddy, N. Sowjanya Reddy and T. Parthasarathy*

Abstract: A reverse phase high performance liquid chromatographic method (RP-HPLC) was developed for the determination of the amount of Telmisartan present in bulk and pharmaceutical formulations. Waters- Alliance High Performance Liquid Chromatographic system equipped with Auto Sampler, PDA detector and Hypersil BDS C18(4.6 × 50 mm, 3 μm) column were used for the method development. Separation of the components were carried out by using composition Ammonium dihydrogen phosphate and Methanol in the ratio 45:55 v/v was allowed as mobile phase at a flow rate of 1.0 mL per minute and the detection of the components was carried out at a wavelength of 298 nm. System suitability parameters such as retention time, tailing factor and USP theoretical plate count of the developed method were found to be 5 minute, 1.1 and 6500 respectively. The linearity between area of the peak and concentration of the drug was found to be 25-300%. The %recovery of Telmisartan were found to be 98.9(50%),98.9(100%) and 99.2(150%) respectively. From the study of forced degradation, the percent of recovery of the drug was found to be 97.2, 95.1, 99.8 and 96.5 under different degradation conditions such as acid (0.2N HCl), alkali (0.2N NaOH), peroxide (30%H2O2) and thermal. The developed method was found to be simple, fast, repeatable, reproducible, robust, rugged and economic hence it can be used as a new analytical method for the analysis of pharmaceutical formulations in any pharmaceutical industries.

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