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Pharm Sci. 2020;26(1): 75-81.
doi: 10.34172/PS.2019.58

Scopus ID: 85084568825
  Abstract View: 128
  PDF Download: 95

Research Article

Stability Indicating Method to Analyze Benidipine and Chlorthalidone Using HPLC Technique: Establishment, Validation and Application to Tablets

Kadali Jagadeesh 1,2, Nowduri Annapurna 2 *

1 Basic Science Department, Shri Vishnu Engineering College for Women, Bhimavaram, Andhra Pradesh, India- 534201.
2 Department of Engineering Chemistry, AU College of Engineering (A), Andhra University, Visakhapatnam, Andhra Pradesh, India -530003.

Abstract

Background: The combination of chlorthalidone and benidipine was used to manage hypertension. The mixture of chlorthalidone and benidipine in tablet dosage form has not been previously determined by any method. A stability indicating HPLC method was developed for the simultaneous determination of benidipine and chlorthalidone in bulk and tablets.

Methods: Chromatographic separation was accomplished in a reverse phase system using an isocratic elution with a mobile phase composed of methanol-0.1M dipotassium hydrogen phosphate buffer (40:60, v/v), at 1 ml/min flow rate. The photodiode array (PDA) detector set at 260 nm was used to detect and quantify benidipine and chlorthalidone. Benidipine and chlorthalidone tablet samples were subjected to degradation under acid, neutral, alkali, thermal, photo and oxidative. The proposed method was effectively adapted to quantify benidipine and chlorthalidone in the combined tablet formulation.

Results: The elution times for benidipine and chlorthalidone were approximately 4.573 min and 6.422 min, respectively. The method was validated within a concentration range of 2 - 6 μg/ml (R2 = 0.9997) for benidipine and 6.25 - 18.75 μg/ml (R2 = 0.9998) for chlorthalidone. Adequate results were obtained for precision (RSD% = 0.106% for benidipine and RSD% = 0.031% for chlorthalidone) and accuracy (99.95 - 100.25 % mean recovery for benidipine and 99.60 - 99.63% mean recovery for chlorthalidone). Robustness has also been found to be acceptable. During the degradation study, interference was not noticed in the analysis of studied drugs.

Conclusion: The findings demonstrated that the method could be useful for determination of the selected drug combination in routine analysis.

Keywords: Benedipine, Chlorthalidone, Degradation, Tablets, HPLC, Analysis
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Submitted: 09 Aug 2019
Revision: 20 Sep 2019
Accepted: 21 Sep 2019
ePublished: 10 Mar 2020
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