Stability-indicating RP-HPLC method development and validation for simultaneous quantification of ciprofloxacin, curcumin, and piperine in a novel topical dosage form

Abstract

An optimized stability-indicating RP-HPLC method has been successfully developed for the concurrent estimation and quantification of Ciprofloxacin, Curcumin, and Piperine. The methodology is strategically optimized with robustness rooted in the principles of sound science. It was validated as per the regulatory guidelines to ascertain its reliability and effectiveness. Analytical conditions provided an incredibly shorter run time of 7 min performed through isocratic elution with acetonitrile: orthophosphoric acid (70:30 % v/v) mobile phase flowing at a rate of 1 mL/min. The optimal wavelength (278 nm) was used in chromatographic detection. The temperature of the column was consistently regulated at 30 °C to produce a thermostable response throughout the chromatograms. Additionally, various forced degradation studies were conducted on the selected drug candidates under stress conditions, including thermal, photolytic, oxidative, and acid-base induction. After stress testing, the samples were subjected to HPLC analysis, demonstrating the method's selectivity in discriminating analytes of interest from degradation byproducts. The designed analytical technique was then validated according to ICH guideline Q2(R1). The developed analytical methodology was subsequently corroborated, including a thorough evaluation of relevant performance attributes such as linearity, system suitability, accuracy, precision, robustness, sensitivity, and solution stability. The results demonstrate that quantifying Ciprofloxacin, Curcumin, and Piperine with wide-ranging applications inside a novel topical dosage form is reliable and precise.