Simultaneous quantitative determination of metoprolol, atorvastatin and ramipril in capsules by a validated stability-indicating RP-UPLC method

Sci Pharm. 2010 Oct-Dec;78(4):821-34. doi: 10.3797/scipharm.1004-14. Epub 2010 Aug 24.

Abstract

A simple ultra performance liquid chromatographic (UPLC) method has been developed for the simultaneous estimation of Metoprolol (MT), Atorvastatin (AT) and Ramipril (RM) from capsule dosage form. The method was developed using Zorbax XDB-C18 (4.6 mm à 50 mm, 1.8 Îm) column with a mobile phase consisting of 0.06% ortho phosphoric acid in Milli Q water having an ion pair reagent, 0.0045 M Sodium lauryl sulphate as buffer, at ratio of buffer: Acetonitrile (50:50 v/v), at 55ÂC column temperature with a flow rate of 1.0 ml/min. Detection was carried out with ultra-violet detection at 210 nm for RM, MT and AT respectively. The retention times were about 1.3, 2.1 and 2.6 min for MT, AT and RM respectively, the method was validated for linearity, accuracy, precision, specificity, robustness and ruggedness. The % mean recoveries are 101.9, 102.1 and 101.4 for MT, AT and RM respectively. The method was found to be rugged and robust and can be successfully used to determine the three drugs and its combinations.

Keywords: Chromatography; Fixed-dose combination; Impurities; Method Validation; Reviro.