METHOD DVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF CLIDINIUM BROMIDE AND CHLORDIZEPOXIDE IN BULK AND TABLET DOSAGE FORM BY A RP- HPLC

Bairam Ravindar* and Yerra Shylaja

ABSTRACT

New method was established for simultaneous estimation of Clidinium bromide and Chlordizepoxide by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Clidinium bromide and Chlordizepoxide by using Inertsil C18 (4.6mm ×250mm, 5μm particle size), flow rate was 1.0 ml/min, mobile phase ratio was (55:45% v/v) Methanol: Phosphate buffer pH 4.8 (pH was adjusted with ortho phosphoricacid), detection wavelength was 282nm. The instrument used was WATERS Alliance 2695 separation module, Software: Empower 2, 996 PDA detector. The retention times were found to be 1.688mins and 3.282mins. The % purity of Clidinium bromide and Chlordizepoxide was found to be 99.86%. The system suitability parameters for Clidinium bromide and Chlordizepoxide such as theoretical plates and tailing factor were found to be 7586, 1.69 and 6235 and 1.58, the resolution was found to be 10.85. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Clidinium bromide and Chlordizepoxide was found in concentration range of 100μg-500μg and 30μg-70μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 100.112% and 100.16%, %RSD for repeatability was 0.1702 and 0.043 respectively. The precision study was precise, robust, and repeatable. The LOD value was found to be 2.1μg/ml and 1.28μg/ml, and LOQ value was 6.3μg/ml and 3.84μg/ml for Clidinium bromide and Chlordizepoxide respectively. The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Clidinium bromide and Chlordizepoxide in pharmaceutical dosage form.

Keywords: Clidinium bromide, Chlordizepoxide, RP?HPLC, Simultaneous estimation.