A Novel Analytical Method for Simultaneous Quantification of Silodosin and Tadalafil by RP-HPLC

Abstract

The Reverse phase HPLC method was developed for simultaneous determination of Silodosin and Tadalafil in single analytical method. Chromatographic separation was achieved on a Supelco C8 (150mmx4.6mm, 5µm) column applying an isocratic elution based on premix of potassium phosphate dibasic buffer pH (4.3) and acetonitrile in the ratio of (70:30 v/v) as mobile. Validation parameters specificity, precision and robustness have been observed to be desirable over the concentration ranges of 80-240 µg/ml for Silodosin and 50-150 µg/ml for Tadalafil in accuracy parameter and 128-192 µg/ml for Silodosin and 80-120 µg/ml for Tadalafil in linearity parameter. All the variables have been studied to optimize the chromatographic conditions. The optimized approach verified through validation and confirmed to be intended purpose for the quality control of the mentioned drugs, as per ICH guidelines. For simultaneous quantification of Silodosin and Tadalafil, the developed method was found to be genuinely exact precise, accurate, linear, fast and cost effective.

Investigating in-vitro functionality and in-vivo taste assessment of eco-friendly Tadalafil Pastilles

“…The solution was shaken for 1 h and kept for 24 h. A 1 ml solution was taken from the stock solution in a 10 ml volumetric flask, and the volume was made with pH 6.8 phosphate buffers. The solution was filtered, and absorbance was measured spectrophotometrically at 284 nm against pH 6.8 phosphate buffer as a blank using a UV double beam spectrophotometer (UV 1800-PC, Shimadzu, USA) [ 77 ].…”

Analytical reversed‐phase high‐performance liquid chromatography method development for silodosin and solifenacin in bulk and marketed formulation using analytical quality by design approach

“…Chemically SLD is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2, 2, 2-trifluoro Ethoxy) phenoxy l] ethyl} amino) propyl]-2, 3-dihydro-1H-indole-7-carboxamide having molecular formula C 25 H 32 F 3 N 3 O 4 as shown in Figure S1A. SLD is a potent antagonist of post-synaptic alpha adrenoreceptors which are found mainly in the human prostate, the base of the bladder, the neck of the bladder, the urethral capsule, and the prostatic urethra [6,7]. Due to the inhibition of alpha-1 adrenoreceptor, the smooth muscles in these tissues may relax which enhances urine flow and lower the BPH symptoms [8,9].…”