Wednesday , 26 July 2017

Analytical Method Development and Validation for the Simultaneous Estimation of Levocetirizine and Candesartan cilexetil by RP-HPLC Method in Bulk and Tablet Dosage Form

K. Naga Prashant, Subhani Shaik*, Dr. J.N. Suresh Babu
Narasaraopeta Institute of Pharmaceutical Sciences, Kotappakonda Road, Narasaraopet-52260, Guntur, Andhra Pradesh, India

A B S T R A C T
The chromatographic conditions were successfully developed for the separation of Levocetirizine and Candesartan cilexetil by using Inertsil-ODS C18 (250 x 4.6 mm, 5 µ), flow rate was 1 ml/min, mobile phase ratio was Methanol: Acetonitrile (90:10 v/v), detection wavelength was 230 nm. The Spectroscopic method was done in solvent using mobile phase and the instrument lab India 3000+ with UV win software. The instrument used was WATERS HPLC Auto Sampler, Separation module 2690, PDA detector, Empower-software version 2. The retention times were found to be 2.789min for Levocetirizine and 3.480 for Candesartan cilexetil. The % purity of Levocetirizine and Candesartan cilexetil was found to be 99.71% and 99.56% respectively. The system suitability parameters for Levocetirizine and Candesartan cilexetil such as theoretical plates and tailing factor were found to be 7983, 1.13 and 9827, 1.07. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Levocetirizine and Candesartan cilexetil was found in the concentration range of 20 ppm-80 ppm and correlation coefficient (r2) was found to be 0.999 and 0.999 respectively, % recovery was found to be within the range of 98% and 101% respectively. %RSD for repeatability and precision was found to be <2. LOD values were 0.33 and 0.32 and LOQ values were 1.01 and 0.98 respectively for Levocetirizine and Candesartan cilexetil.
Keywords: Levocetirizine, Candesartan cilexetil, RP-HPLC.

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