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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RAMIPRIL IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-UPLC

Akash Mittal, Priyadarshani Kamble, R. P.S Rathore

Abstract


Objective: To develop and validate a new very rapid, sensitive, reverse phase Ultra Performance Liquid Chromatography (RP-UPLC) technique for the estimation of Ramipril in dosage form, as there is no official monograph & no analytical method by UPLC. Methodology: Chromatographic separation was achieved on a Xbridge BEH C18 column (50 x 2.1 mm, 2.5μm) using a gradient method with mobile phase composed of 0.1% trifluoro acetic acid and acetonitrile in the ratio 80:20 v/v. The flow rate was 0.6 ml/min, temperature of the column was maintained at ambient and detection was made at 210 nm. The run time was as short as 3.0 min. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, specificity and robustness. Results: The developed method was linear for Ramipril from 50 - 250 μg/ml and the linear regression obtained was > 0.99. Precision, evaluated by intra- and inter-day assays had relative standard deviation (R.S.D) values 0.27%. Recovery data were in the range 98.04% to 98.17%. Conclusion: The method is precise, accurate, linear, robust and fast. The short retention time of 1.08 min allows the analysis of a large number of samples in a short period of time and, therefore, should be cost-effective for routine analysis in the pharmaceutical industry.

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