Application of chemometric approach for development and validation of high performance liquid chromatography method for estimation of ropinirole hydrochloride

Abstract

A systematic Quality by Design approach was employed for developing an isocratic reversed‐phase liquid chromatographic technique for the estimation of ropinirole hydrochloride in bulk drug and pharmaceutical formulations. LiChrospher RP 18‐5 Endcapped column (25 cm × 4.6 mm id) at ambient temperature (25 ± 2°C) was used for the chromatographic separation of the drug. The screening of factors influencing chromatographic separation of the active pharmaceutical ingredient was performed employing fractional factorial design to identify the influential factors. Optimization of the selected factors was carried out using central composite design for selecting the optimum chomatographic conditions. The mobile phase employed was constituted of Solvent A/Solvent B (65:35 v/v) (Solvent A [methanol/0.05 M ammonium acetate buffer, pH 7, 80:20 v/v] and Solvent B [high performance liquid chromatography grade water]) and used at 0.6 mL/min flow rate, while UV detection was performed at 250 nm. Linearity was achieved in the drug concentration range 5–100 µg/mL (R2 = 0.9998) with limits of detection and quantification of 1.02 and 3.09 µg/mL, respectively. Method validation was performed as per ICH guidelines followed by forced degradation studies, which indicated good specificity of the developed method for detecting ropinirole hydrochloride and its possible degradation products in the bulk drug and pharmaceutical formulations.

Danggui Buxue Decoction: Comparative pharmacokinetic research on six bio‐active components in different states by ultra‐performance liquid chromatography‐tandem mass spectrometry after oral administration

“…Assays for method validation were conducted according to the currently accepted ICH Q2 (R1) guideline [15–16]. Method validation was performed in rat plasma and tissues.…”

“…Assays for method validation were conducted according to the currently accepted ICH Q2 (R1) guideline [15][16].…”

Chemometrics Approaches in Forced Degradation Studies of Pharmaceutical Drugs

“…All these techniques generate a great amount of data, and the manual data mining is very time and money consuming. In this context, chemometric tools can present a way to organize and pre-process data, optimize parameters of HPLC, MS, and NMR techniques, obtain the maximum knowledge about them, and clarify a lot of useful information [51,58,59].…”

Novel experimental design paradigm for development of eco‐friendly gradient chromatographic method for simultaneous determination of metronidazole and spiramycin

“…Various experimental designs have been performed during the validation, development, and optimization of different analytical procedures [4][5][6][7][8][9][10][11][12][13][14][15][16]. Implementation of experimental designs has extended to the optimization of extraction procedures [17][18][19][20] and analysis of complicated mixtures and chiral separations [21][22][23].…”