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 × 50 mm, 1.8 μm) 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 55°C 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.
New stability indicating chromatographic methods have been developed for estimation of Assay and Impurities of Docetaxel in Docetaxel injection for evaluation of pharmaceutical quality. With this method, the process related impurities and degradants are well separated from the peaks due to placebo. The relative retention times and relative response factors of the known impurities have been established. The LOQ of the known impurities and docetaxel are found to be less than 0.2 μg /ml and the recovery falls in the range of 90–110%. Peak purities demonstrated the stability indicating nature of the methods. The methods developed in the present study overcome the lacunae of the existing published methodologies in evaluation of the quality of Docetaxel injection. In essence, the present study provides an improved methodology for evaluation of the pharmaceutical quality of Docetaxel injection.
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