A Validated Simple, Rapid and Accurate RP-HPLC Approach for Measuring Vardenafil Hydrochloride Trihydrate in Bulk Drugs and Medicinal Formulations
1, 2, 2, 3
- 1Department of Pharmaceutics, Appasaheb Birnale College of Pharmacy-Sangli, South Shivaji Nagar, Sangli, Maharashtra, INDIA.
- 2Krishna Institute of Pharmacy, Krishna Vishwa Vidyapeeth (Deemed to be University), Malkapur, Karad, Maharashtra, INDIA.
- 3Department of Pharmaceutical Chemistry, Rajarambapu College of Pharmacy, Kasegaon, Walwa, Sangli, Maharashtra, INDIA.
CORRESPONDENCE
Mr. Ganesh Ramesh Gadekar
Department of Pharmaceutics, Appasaheb Birnale College of Pharmacy-Sangli, South Shivaji Nagar, Sangli-416416, Maharashtra, INDIA.
Received: 09-03-2023; Accepted: 07-03-2024.
Volume 58, Issue 2s (Supplement) · pp. s532-s542 · 2024 · DOI: 10.5530/ijper.58.2s.55
ABSTRACT
Background: Shortcomings in current analytical methods characterized by time-consuming procedures, limited sensitivity, and high costs associated with reagents and instruments, influence the research background.Objectives: The goal of this research was to find a simple, fast, and accurate way to discern and quantify substances in bulk drugs and finished products at the utmost minimal levels of detection and quantification.Materials and Methods: The methodology involved using a C18 column then a solvent mixture comprising 0.1% orthophosphoric acid and acetonitrile in an 80:20 proportion delivered at 1 mL/min-1 and observed at 247 nm with a UV detector.Results: Following rigorous verification in line with ICH guidelines, the technique revealed several notable features. It revealed rapidity with a retention time of 2.53 min, accurate with average recoveries ranging from 99.20% to 100.43%, precision as demonstrated by a relative standard deviation below 2%, specificity, and a highly linear correlation coefficient of 0.999 between 0.0025 to 6 μg mL-1. Additionally, the method displayed remarkable sensitivity, detecting concentrations as low as 56.91 ng mL-1 and a quantification limit of 172.44 ng mL-1.Conclusion: This tested RP-HPLC method has a unique mix of speed, accuracy, and high sensitivity that makes it possible to accurately measure Vardenafil hydrochloride trihydrate, even at nanogram levels. This surpasses established techniques and offers a cost-effective solution for pharmaceutical quality control and analysis.
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Gadekar, G. R., Doijad, R. C., Jadhav, N. R., & Bhinge, S. D. (2024). A Validated Simple, Rapid and Accurate RP-HPLC Approach for Measuring Vardenafil Hydrochloride Trihydrate in Bulk Drugs and Medicinal Formulations. Indian Journal of Pharmaceutical Education and Research, 58(2s), s532-s542. https://doi.org/10.5530/ijper.58.2s.55
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