A Stability Indicating RP-HPLC Method for Simultaneous Estimation
of Solifenacin and Silodosin in Bulk and Formulation
P Swetha1, J Sumalatha2* and S Nelson Kumar3
1Department of Pharmaceutical Analysis, P. Rami Reddy Memorial College of
Pharmacy, Kadapa, Andhra Pradesh, – 516003, India
2Department of Pharmaceutical Chemistry, P. Rami Reddy Memorial College of
Pharmacy, Kadapa, Andhra Pradesh, – 516003, India
3Department of Pharmacology, P. Rami Reddy Memorial College of Pharmacy,
Kadapa, Andhra Pradesh, – 516003, India
*Corresponding Author: J Sumalatha, Department of Pharmaceutical Chemistry,
P. Rami Reddy Memorial College of Pharmacy, Kadapa, Andhra Pradesh, – 516003,
India.
Received:
April 30, 2026; Published: May 26, 2026
Abstract
A new RP-HPLC method was established for the concurrent measurement of Solifenacin and Silodosin in pharmaceutical products,
characterized by its speed, precision, and sensitivity. To achieve effective separation, the researchers utilized a Waters Alliance e2695
system paired with a Hyperclone C18 column (250 × 4.6 mm, 5 μm). The process involved a mobile phase composed of acetonitrile
and 0.1% formic acid (50:50 v/v), which was delivered at a constant flow rate of 1.0 mL/min. Analysis was performed at ambient
temperature, with detection set at a wavelength of 272 nm using a PDA detector. The integrity of the system was confirmed through
suitability parameters, which recorded theoretical plates exceeding 2000 and a tailing factor under 2.0 for both active ingredients.
Additionally, the %RSD remained below 2.0, showcasing the method’s high level of reproducibility and precision. This analytical
approach was fully validated according to ICH guidelines, proving to be a robust, accurate, and budget-friendly option. Because it
operates without interference from pharmaceutical excipients, it is highly recommended for routine laboratory analysis and stability
testing of Solifenacin and Silodosin.
Keywords: RP-HPLC; Solifenacin and Silodosin; Method Validation; Stability Studies
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