Application of Analytical Validated High-Performance Thin-Layer Chromatographic Technique for the Multicomponent Analysis of Cardiovascular Drug Combos in Pharmaceutical Dosage Form

摘要

Dyslipidemia, which may be manifested by elevation of the total cholesterol concentration in the blood, is one of the most common medical conditions that affect individuals. This work presents a simple, fast, and precise high-performance thin-layer chromatography (HPTLC) technique for the multicomponent analysis of rosuvastatin (Ros) and fenofibrate (Fen), Ros and ezetimibe (Eze), and Ros and aspirin (Asp) in three different pharmaceutical combos prescribed for the treatment of dyslipidemia. Techniques were performed on silica gel 60 F-254 TLC precoated aluminum plates with a simple mobile phase combination of toluene-acetone-acetic acid in the ratio of 6: 2:0.2 v/v and produced well-resolved compact spot for all titled drugs. The linear regression statistics has shown a good linear relationship over a concentration range of 500-4000 ng spot(-1) for all cited drugs with a good correlation coefficient of 0.9999, and densitometric detection was carried out in the absorbance mode at 254 nm. The sensitivity of the developed technique was assessed in terms of the limit of quantification and the limit of detection. The stability study disclosed that all four drugs were stable at room temperature up to 12 h. The cited drugs were validated as per International Conference on Harmonization (ICH) guidelines. The technique was found to be specific and selective since no extra peak was recorded alongside with the main peak. The robustness study, recovery study, and the percentage of the assay of the formulations were found within the limit as per ICH guidelines. Marketable tablets were also analyzed for five different brands by the developed methodology with no interference detected from the excipients in the formulations. The cost-effectiveness, sensitivity, and selectivity of the proposed technique recommend its applicability for the routine quality-control analysis of any of the named drugs in their pharmaceutical preparations.