Friday , 29 March 2024

Analytical Method Development and Validation for the Simultaneous Estimation of Atenolol and Nitrendipine by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

Gobala Krishnan P*, Munisekhar V, Ranjit Singh B. Rathore
Department of Pharmaceutical Chemistry, Vagdevi College of Pharmacy & Research Centre, Nellore, A.P, India

A B S T R A C T
A new method was established for simultaneous estimation of Atenolol and Nitrendipine by RP-HPLC method.  The chromatographic conditions were successfully developed for the separation of Atenolol and Nitrendipine by using Phenomenox Luna C18Column, 5µ (250 × 4.6mm), flow rate was 1.5ml/min, mobile phase ratio was Methanol : Acetonitrile : Water (40 : 40 : 20) pH was adjusted to 3.0 with Orthophosphoric acid, detection wave length was 235nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2. The retention times were found to be 2.621 mins and 5.169 mins. From the Linearity study, it was found that, the drug obeys beer’s law and the specified range for estimation of Atenolol and Nitrendipine was found to be 60% to 140%. Correlation coefficient was found to be R2=0. 0.9989 and R2=0.9992 respectively for Atenolol and Nitrendipine. Limit of Detection and  Quantitation  for Atenolol was found to be 1.964 µg/ml and 5.952  µg/ml  respectively. Limit of Detection and Quantitation  for Nitrendipine was found to be 0.342  µg/ml  and 1.036 µg/ml  respectively. Precision RSD was found to be 0.710 for Atenolol and 0.822 for Nitrendipine. Whereas Intermediate Precision RSD was found to be 0.445 for Atenolol and 0.668 for Nitrendipine. The precision was found to be within the specified limit which indicates that the method is precise. From the accuracy study, it was found that recovery value of pure drug from the solution were between 98.0 % to 102% which indicates that the method is accurate. RSD with decreased flow rate of mobile phase for Atenolol was 0.285% and for Nitrendipine it was 0.195%. While with increased flow rate of mobile phase RSD for Atenolol was 0.226% and for Nitrendipine it was 0.373 %. RSD with decreased Wavelength of Detector for Atenolol was 0.263% and for Nitrendipine it was 0.449%. While with increased Wavelength of Detector RSD for Atenolol it was 0.874 % and for Nitrendipine it was 0.191%. In both conditions the R.S.D. was less than 2%.
Keywords: Atenolol, Nitrendipine, HPLC

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