DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF FEXOFENADINE IN PHARMACEUTICAL DOSAGE FORM BY USING LEVOCETIRIZINE AS AN INTERNAL STANDARD

Author(s): Narender Malothu*, Tejaswini Paladugu, Padmalatha Katamaneni

Abstract: A simple, accurate and precise RP-HPLC method was developed and validated for determination of Fexofenadine in pharmaceutical dosage form by using Levocetirizine as an Internal standard (IS). The separation was achieved by Cap Cell Pack C18 column (250 × 4.5 mm, 5µ) column using acetonitrile: water (50:50 % v/v) as eluent at a flow rate of 1 mL/min, detection was carried out at 224 nm. The retention times for Fexofenadine and IS were found at 4.79 and 6.22 mins, respectively. Linearity was observed over the concentration ranging from 50-175 µg/mL and it was found to be linear with y = 0.011x + 0.168 (r2 = 0.997). The precision of the method was demonstrated with % RSD values of < 2% while the % recovery was found in between 101.3-101.5%. Interference of the any additive components of formulations was not observed. Based on results obtained the proposed method was found to be accurate, specific and precise and could be applied to quantitative analysis of Fexofenadine by using Levocetrizine as IS.

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