ABSTRACT

The research presents a method for developing and validating analytical methods for treating newer high-level low-density lipoproteins (LDL) using Bempedoic acid, which is an alternative treatment for primary hyperlipidaemia in patients. The objective of this study was to provide an easy, fast, sensitive, accurate, precise, and economical technique for estimating Bempedoic acid in pharmaceutical and bulk items by The proposed method made use of a Acetonitrile: Water 70:30% v/v mobile phase with an optimum flow rate of 1.0 ml/min via Box Behnken Design Expert 7.0. Inertsil ODS-3V (150 mm X 4.6 mm i.d.) 5 ?m C18 column used for method development and wavelength detection at 212 nm. The retention time of Bempedoic acid was 4.25 minutes. After developing a method according to ICH guidelines, validation is complete. The linearity of the correlation coefficient of the developed method was found to be 0.996. The limit of detection (LOD) and limit of quantification (LOQ) for Bempedoic acid were found to be 16.34 and 49.52 ?g/ml respectively. For RP-HPLC, several system suitability parameters were found to be specific according to ICH guidelines, viz. tailing, theoretical plates, resolution. The QBD approach was with RP-HPLC during method development and helps make all methods sensitive and cost-effective. Keywords: Bempedoic Acid, RP-HPLC, Quality by Design, Box Behnken Design, Development, Validation
Publication date: 01/10/2025

https://ijbpas.com/pdf/2025/October/MS_IJBPAS_2025_9536.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.10.9536