World Journal of
Pharmaceutical and Life Sciences

ANALYTICAL METHOD VALIDATION REPORT FOR ASSAY OF ROSUVASTATIN AND BEMPEDOIC ACID BY HPLC

Bandi Shilpa*, M. Murali Mohan, G. Sowmya and A. Yasodha

ABSTRACT

Analytical Method Development and Validation for Bempedoic acid and Rosuvastatin in bulk and Combined Dosage Form by RP-HPLC. New method was established for simultaneous estimation of Bempedoic acid and Rosuvastatin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Bempedoic acid and Rosuvastatin 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 phosphoric acid), 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 Bempedoic acid and Rosuvastatin was found to be 99.86%. The system suitability parameters for Bempedoic acid and Rosuvastatin 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 Bempedoic acid and Rosuvastatin 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 Bempedoic acid and Rosuvastatin respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Bempedoic acid and Rosuvastatin in API and Pharmaceutical dosage form.

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