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  • Chem Sci Trans., 2014, 3(1),  pp 193-200  

    DOI:10.7598/cst2014.696

    Research Article

    Development and Validation of RP - HPLC Method for the Simultaneous Estimation of Candesartan Cilexetil and Levocetirizine Hydrochloride

  • S. LAKSHMI, M. S. NIRANJAN, P. L. SOMASHEKAR and C. E. RAJENDRA
  • Department Pharmaceutical Chemistry, Government College of Pharmacy,
    Bangalore, Karnataka- 560 027, India
    Drugs Testing Laboratory, Palace Road, Bangalore, Karnataka- 560 001, India
  • Abstract

    In the present work, a rapid, accurate and precise RP-HPLC method was developed for simultaneous estimation of candesartan cilexetil(CAN) with levocetrizine hydrochloride(LEV) using a physical mixture of these two drugs. A new method was developed using phenominex C8 column (250 mm x 4.6 mm, 5 µ) as stationary phase and mobile phase consists of acetonitrile: Buffer (Heptane sulphonic acid) in ratio 80:20 (pH 4.4) with a flow rate of 1 mL/min and UV detection was performed at 230 nm. The retention time of LEV and CAN were found to be 2.8 ±0.02 min and 4.8 ±0.02 min respectively. The method was validated by using various validation parameters like linearity, accuracy, precision, specificity, stability and robustness. Linearity was observed in the concentration range of 1-30 µg/mL for LEV and CAN with good regression response of 0.999. The LOD of LEV and CAN was observed to be 100 µg/mL and 50 µg/mL, the LOQ of LEV and CAN was observed to be 600 µg/mL and 300 µg/mL respectively. Accuracy of the method was performed by recovery studies and the percentage recoveries obtained for LEV and CAN were 100.8% and 99.69% respectively. Precision studies were carried out and %RSD was found to be 0.91 and 1.44 for LEV and CAN for system precision and 1.55 and 1.54 for LEV and CAN for method precision respectively. All the validation parameters were found to be well within the acceptance criteria. Hence the method can be used for routine estimation of LEV and CAN in bulk drug and pharmaceutical formulations both in individual and in combination.

    Keywords

    RP-HPLC, Candesartan cilexetil, Levocetrizine hydrochloride

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