A Validated Simple, Rapid and Accurate RP-HPLC Approach for Measuring Vardenafil Hydrochloride Trihydrate in Bulk Drugs and Medicinal Formulations

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.

KEYWORDS

• RP-HPLC
• Vardenafil hydrochloride Trihydrate
• LOD
• Nanogram

Showing references and in-text citations exactly as published.

• DOI10.5530/ijper.58.2s.55Copy

RELATED ARTICLES

Matched on section and article type within this issue of IJPER.

• Article · VOLUME 58, ISSUE 2SClinical Efficacy and Safety of Ceftriaxone in Surgical Prophylaxis: A Systematic Review and Meta-AnalysisShwetha Somakumar, S Elstin Anbu Raj, Gabriel Sunil Rodrigues, V Rajesh · pp. s332–s339Original ArticleSame type: Article
• Article · VOLUME 58, ISSUE 2SA Biochemical and Molecular Insight to Wound Healing Properties of Traditional Indian Medicines in Normal and Diabetic RatsSushma Prabhath, Kumar M R Bhat, K. Sreedhara R Pai, Manas Kinra, Karthik Gourishetti · pp. s359–s371Original ArticleSame type: Article
• Article · VOLUME 58, ISSUE 2SChlorogenic Acid, a Potential Glucose-6-Phosphatase Inhibitor: An Approach to Develop a Pre-Clinical Glycogen Storage Disease Type I ModelSantosh B Patil, Pramod C Gadad · pp. s372–s381Original ArticleSame type: Article
• Article · VOLUME 58, ISSUE 2SIdentification of Phorbol Ester and its Degradation by Traditional Purification Method in the Root of Baliospermum montanum (Willd.) Muell. ArgJayshree Vishnupant Changade, Ashwini Shete, Asha Thomas, Rabindra K Nanda · pp. s382–s388Original ArticleSame type: Article