Abstract

DEVELOPMENT AND VALIDATION OF NEW RP-UPLC METHOD FOR THE QUANTITATIVE DETERMINATION OF NIFEDIPINE IN PURE & PHARMACEUTICAL DOSAGE FORM

Sunitha Rani Ajmera*

ABSTRACT

The main aim of the work is to develop and validate a new, rapid, sensitive, reverse phase Ultra Performance Liquid Chromatography (RP-UPLC) technique for the estimation of Nifedipine in pure and capsule dosage form. Chromatographic separation was achieved on a Waters Acquity UPLC HSS T-3 C18 column (100 × 2.1 mm, 1.7μm) using an isocratic method with mobile phase composed of (0.1% Orthophosphoric acid +0.2% Tert-butyl ethyl ether): methanol in the ratio 40:60 v/v. The flow rate was 0.6 ml/min, temperature of the column was maintained at ambient and detection was made at 235 nm. The run time was as short as 4 min. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, specificity and robustness. The developed method was linear for Nifedipine from 30-480 μg/ml and the linear regression obtained was > 0.999. Precision, evaluated by intra- and inter-day assays had relative standard deviation (R.S.D) values within 2.0%. Recovery data were in the range 99.5% to 100.9% with R.S.D. values < 2.0%. The method is precise, accurate, linear, robust and fast. The short retention time of 2.521 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.

Keywords: Nifedipine, UPLC, new method development, validation.