Validated high-performance thin-layer chromatographic method for quantitation of fluvoxamine in the presence of degradation products formed under ICH recommended stress conditions

Abstract

This paper describes a sensitive, selective, precise, and stabilityindicating high-performance thin-layer chromatographic method for the determination of fluvoxamine as a bulk drug and in formulation. The method uses aluminium plates precoated with silica gel 60 F-254 as the stationary phase and solvent system ethyl acetatetoluene-methanol-ammonia 7:2:1:0.5 (v/v/v/v). Fluvoxamine was subjected to acid and alkali hydrolysis, oxidation, and photodegradation. The peaks of the degradation products were well resolved from that of the pure drug and had significantly different R F values. The linear regression analysis data for the calibration plots showed a good linear relationship over a concentration range of 100-1000 ng spot -1 . The mean values of the correlation coefficient, slope, and intercept were 0.9992 ± 0.02, 9.8493 ± 0.347, and 386.8 ± 0.71, respectively. Statistical analysis showed that the method is repeatable, selective and can separate the drug from its degradation products and can be used to monitor stability.

A facile on–off fluorescence approach for fluvoxamine determination in pharmaceutical tablets; application to content uniformity testing

“…2 Reviewing the literature shows that there are numerous approaches for determining the medication under investigation. These strategies include: spectrophotometry, 3-6 spectrouorimetry, [7][8][9][10][11][12] liquid chromatography (HPLC), [13][14][15][16][17][18] gas chromatography (GC), 19 thin layer chromatography, [20][21][22] electrochemical methods, [23][24][25] and capillary electrophoresis. 26 HPLC necessitates the use of expensive instruments and huge quantities of highly pure liquids.…”

Stability-Indicating RP-HPLC Method for the Quantification of Paliperidone in Bulk and Solid Dosage Form to Establish Validation and Stability Indicating Parameters

“…It is prescribed for the treatment of acute schizophrenia and schizoaffective disorder. [3][4][5] Different analytical methods have been reported in the literature for quantifying paliperidone in API and its marketed formulations, which include UV-visible spectrophotometer, 6 HPLC with UV detector, [7][8][9][10] UHPLC-MS/MS 11 and HPTLC. 12 Among them, most of the reported analytical methods in the literature have either had more retention time, usage of buffers or have tedious analytical procedures which leads to turnout samples were less thereby the existing method are not economical.…”

Analytical Quality-By-Design Compliant Ultrafast Liquid Chromatographic Method for Determination of Paliperidone in Extended Release Tablet Dosage Form

“…Several analytical methods have been developed for estimation of paliperidone in pharmaceutical dosage forms and biological samples including spectrophotometric [2][3][4], high performance liquid chromatography(HPLC) [5][6][7][8][9][10][11][12], ultra performance liquid chromatography (UPLC) [13][14][15], high performance thin layer liquid chromatography(HPTLC) [16,17] and liquid chromatographymass spectrometry(LC-MS) [18,19] methods. However, these reported chromatographic methods for estimation of paliperidone possess multiple drawbacks like traditional method development procedure, low sensitivity, complex mobile phase mixture, strict monitoring of critical method parameters like mobile phase flow rate, column temperature, flow gradient, maintenance of pH, etc.…”