Saturday , 8 May 2021

Development and Validation of Micellar Electrokinetic Chromatographic Assay Method for Simultaneous Estimation of Antihypertensive Drugs in Pharmaceutical Formulations

A. Ramyasree1*, Dr. R. Sekar2
1NRI college of Pharmacy, Vijayawada, Andhra Pradesh
2Indian Institute of Chemical Technology (IICT), Hyderabad, Telangana

A micellar electrokinetic capillary chromatographic (MEKC) method has been developed for the simultaneous determination of anti-hypertensive drugs amlodipine (AM) and lisinopril (LS) in pharmaceutical formulations. Analysis was performed in a 75 µm ID uncoated fused-silica capillary with 50 cm length using a buffer consisting of 12.5 mM sodium dodecyl sulphate (SDS) and 10 mM sodium tetraborate (STB), with pH 9.7. All analytes were separated within 11 min with the applied voltage of +25 kV (current ~ 50 µA). Samples were injected hydrodynamically by applying 25mbar pressure for 12 s. The developed method was validated in terms of linearity, accuracy, precision, limit of quantitation (LOQ), and limit of detection (LOD). The intra- and inter-day precision for amlodipine and lisinopril were 1.02, 1.81, 1.51, and 1.68 respectively.  The linearity of method was tested over the range of 5-100 µg/ml (r2 = 0.998) for AM, (r2 = 0.999) for LS. Recovery of standard mixtures was found to be ≥99.56% with the relative standard deviation (RSD) ≤1.30%. The LOQ were 2.5 µg/ml, (RSD. 1.10%, n=5), 2.0 µg/ml, (RSD. 0.98%, n=5), LOD were found to be 1.0 and 0.5 µg/ml for AM and LS respectively. The method was applied for the analysis of both drugs in combined dosage form.  The average content of the both drugs in pharmaceutical formulations were ranging from 98.6 to 101.8% respectively. The present method is also suitable for the determination of counter ion besylate (benzene sulphonate) in pharmaceutical formulations.
Keywords: Micellar electrokinetic capillary chromatography, amlodipine, lisinopril, pharmaceutical formulations

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