Abstract
For the first time a simple, rapid and accurate stability indicating HPLC method is described for simultaneous quantification of atenolol and nifedipine in bulk powder and dosage form. Chromatographic separation was carried out on Intersil® reversed phase C18 column. Separation was done using gradient binary mobile phase of ACN and 50 mM NaClO4 in the ratio from 5: 95 to 50: 50 (v/v) within 8 minutes at flow rate of 1 mL/min and 30 °C. An UV detector was used at 230 nm for detection. The elution times of atenolol and nifedipine were found to be 6.05±0.02 and 14.50±0.04 minutes, respectively. The method was validated for system suitability, linearity, precision, limits of detection and quantitation, specificity, stability and robustness. Robustness study was done for small changes in temperature, flow rate, wavelength of detection and time to reach 50% of ACN in mobile phase. Stability tests were done through exposure of the analytes' solution for five different stress conditions. The limit of detection for both drugs was 0.04 µg mL-1. Limits of quantitation were found to be 0.12 µg mL-1 for atenolol and 0.11µg mL-1 for nifedipine. The recovery value of this method was 100.40±0.85% for atenolol and 100.30±1.10% for nifedipine.
Highlights
Atenolol, 4-(2-hydroxy-3-isopropylamminopropoxy) phenylacetamide (Fig. 1), is a cardioselective beta blocker lacking intrinsic sympathomimetic activity
For the first time a simple, rapid and accurate stability indicating HPLC method is described for simultaneous quantification of atenolol and nifedipine in bulk powder and dosage form
Robustness study was done for small changes in temperature, flow rate, wavelength of detection and time to reach 50% of ACN in mobile phase
Summary
4-(2-hydroxy-3-isopropylamminopropoxy) phenylacetamide (Fig. 1), is a cardioselective beta blocker lacking intrinsic sympathomimetic activity It is clinically used in the management of hypertension, angina pectoris, cardiac arrhythmias and myocardial infarction (Sweetman, 2006). There are various papers describing determination of each of atenolol and nifedipine alone or in combination with other drugs, only few papers described the determination of both drugs in combination by derivative spectrophotometry (Umapathi, 1994; Kasture, 2005; Veronico et al, 1995; Sabel et al, 2012), HPTLC (Ramteke et al, 2010) and liquid chromatographic methods (Bing et al, 2004; Hui et al, 2004; Vidyadhara et al, 2012; Kallem et al, 2013). It was important to find a new sensitive stability indicating method without using ion pairing agent for simultaneous quantitative determination of both drugs in combination
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