VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF LOVASTATIN AND OLEANOLIC ACID IN ANTILIPIDEMIC TABLETS

In the modern era, rapid high-performance liquid chromatography (HPLC) is the most effective system for the separation of active pharmaceutical ingredients for pharmaceutical analysis due to its extremely effective separation with high sensitivity and accuracy. Establishing and validating an analytical technique using HPLC is essential for upholding the quality of products, as it gives data on accuracy, linearity, precision, and detection. This study focused on developing and validating an HPLC technique for effective evaluation of lovastatin (LV) and oleanolic acid (OA) in core and coat antilipidemic tablets formulated. RP-HPLC process for concurrent assessment of lovastatin also oleanolic acid was performed by means of a Jasco HPLC scheme in addition SunQSil C18 4.6 × 250 mm column (5 μm). The mobile phase utilized for the proposed method was Methanol as well as Water (90:10 v/v), the mobile phase was adjusted to pH 3 using orthophosphoric acid, with a flow rate of 1 mL per min, also finding of both drugs was performed at 210 nm. The validation of the proposed method was carried out in accordance with ICH Q2 (R1) guidelines. Retention time of Lovastatin, in addition to Oleanolic acid, was identified as 4.41 also 6.43 min, respectively. Linearity for Lovastatin also Oleanolic acid was measured in the interval of 2-12 µg/mL with mean percent recovery of 99.99% and 99.82%, respectively. The method demonstrated satisfactory precision, as the percentage relative standard deviation values for both intra- and inter-day precision were below 2%. The proposed simultaneous estimation technique presented exceptional precision, accuracy, linearity, as well as robustness. This simple technique may effectively be applied for the simultaneous estimation of LV as well as OA in therapeutic dosage form. This contributes significantly to ensuring the safety and efficacy of antilipidemic drugs, supporting broader public health goals.