Micellar electrokinetic capillary chromatographic determination of a polypill combination containing, lisinopril, hydrochlorothiazide, aspirin, and atorvastatin

Abstract

A simple, precise, and rapid micellar electrokinetic capillary chromatographic method with a photodiode array detector was developed and validated for the separation and simultaneous determination of a cardiovascular innovative polypill combination. The combined polypill components were: lisinopril (LIS), hydrochlorothiazide (HCT), aspirin (ASP), and atorvastatin (ATO). Separation was achieved utilizing a fused silica capillary (58 cm × 75 μm ID) and a background electrolyte solution consisting of borax buffer (20 mM, pH 9.5) containing 30 mM sodium lauryl sulphate, with paracetamol as the internal standard. The method was fully validated as per the guidelines of the International Conference on Harmonization for validation of analytical procedures. The method was linear over the range 0.1–200 μg mL⁻¹ with detection limits of 3.10, 0.33, 0.74, and 0.84 μg mL⁻¹ for LIS, HCT, ASP, and ATO, respectively. The proposed method was successfully applied for the simultaneous determination of the polypill components without interferences from the common pharmaceutical excipients. The percentage recoveries of the four drugs from the polypill were 100.07 ± 0.81, 100.30 ± 0.21, 99.73 ± 0.40, and 99.23 ± 0.49% for LIS, HCT, ASP, and ATO, respectively. The method is rapid as it involved a short run time; all the components were eluted within 8 min. Moreover, the method also permitted the separation of salicylic acid which is commonly present in aged aspirin formulations. The results demonstrated that the proposed method has a great practical value for routine application in quality control laboratories for the high-throughput simultaneous determination of the polypill components.