Author(s):
Manish Kumar, Umesh Chandra, Arun Garg, Pankaj Gupta
Email(s):
manish.krmu2018@gmail.com
DOI:
10.52711/0974-360X.2022.00327 
Address:
Manish Kumar*, Umesh Chandra, Arun Garg, Pankaj Gupta
Department of Pharmaceutical Sciences, School of Medical and Allied Sciences, K.R. Mangalam University, Sohna Road, Gurugram, Haryana-122003.
*Corresponding Author
Published In:
Volume - 15,
Issue - 5,
Year - 2022
ABSTRACT:
The present analytical study aims to develop and validate the RP-HPLC method for dissolution of Azelnidipine (AZE) and Telmisartan (TEL) in fixed-dose combination tablets (8 mg/40 mg) and also to demonstrate that the test method used, is suitable for its intended purpose as per ICH guidelines. The protocol developed utilizes Inertsil ODS 3V, C18 column 150 x 4.6 mm, 5 µm particle sizes, column oven temperature 40°C with a flow rate of 1.5 mL/min. The volume of injection was kept at 10 µL and run time 11.0 minutes at 254 nm using Acetonitrile and buffer as mobile phase in gradient mode. Thus developed method after validating on different parameters was found to be complying with system suitability, specificity, precision, intermediate precision, accuracy, linearity, robustness, and solution stability found to meet the predetermined acceptance criteria.
Cite this article:
Manish Kumar, Umesh Chandra, Arun Garg, Pankaj Gupta. Development and Validation of In-vitro dissolution test using RP-HPLC Analysis for simultaneous estimation of Azelnidipine and Telmisartan in a Fixed-dose Combination. Research Journal of Pharmacy and Technology. 2022; 15(5):1967-2. doi: 10.52711/0974-360X.2022.00327
Cite(Electronic):
Manish Kumar, Umesh Chandra, Arun Garg, Pankaj Gupta. Development and Validation of In-vitro dissolution test using RP-HPLC Analysis for simultaneous estimation of Azelnidipine and Telmisartan in a Fixed-dose Combination. Research Journal of Pharmacy and Technology. 2022; 15(5):1967-2. doi: 10.52711/0974-360X.2022.00327 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2022-15-5-9
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