RP-HPLC stability-indicating method for simultaneous determination of sodium valproate, methylparaben and propylparaben in oral solution

Abstract

A new, sensitive, stability-indicating reversed-phase HPLC method was validated and applied for the simultaneous quantitation of sodium valproate and two paraben preservatives; methylparaben, and propylparaben in the liquid dosage form. Stability tests were carried out through exposure of the analyte's solution to stress conditions. Separation of the analytes was achieved on (waters) C18 Column (150 mm × 3.9 mm, 5 μm). A mixture of 0.05 M monobasic potassium phosphate pH 3.5 and acetonitrile (50:50; v/v) was applied at 1.5 ml/min flow rate and UV detection wavelength at 210 nm. The degradation products and the analytes were completely separated. The linearity was performed in the range of 50–150 % from a target concentration of 10 μg/ml propylparaben, 90 μg/ml methylparaben, and 2.88 mg/ml sodium valproate with a coefficient correlation (R2) 1.0 for methylparaben, propylparaben and sodium valproate. The validation results of the suggested method were in a good agreement with ICH guidelines. Application of the proposed method for analysis of liquid dosage forms was successfully carried out in the routine quality control process.

Use of TLC-Densitometric Method for Determination of Valproic Acid in Capsules

“…The limits of detection of valproic acid obtained in this study have higher values than those cited in this table. The values of the limit of detection of valproic acid obtained in this work by TLC using the 2 ,7 -dichlorofluorescein-aluminum chloride-iron (III) chloride system have similar values to the limit of detection values obtained during the determination of valproic acid in pharmaceutical preparations using the RP-HPLC [20] and square wave voltammetry [41].…”

“…They are useful in monitoring the therapeutic concentration of a substance, treatment progress, and side effects. Several methods for determination of valproic acid are known, namely: thin layer chromatography [5], liquid chromatography [6][7][8][9], high performance liquid chromatography [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24], ultra high performance liquid chromatography [4,25,26], ultra performance liquid chromatography [27][28][29][30][31], gas chromatography [4,18,[32][33][34][35][36][37][38], capillary electrophoresis [39,40], voltamperometry [41], valproateselective electrode [42], and colorimetry [43].…”

“…The vast majority of valproic acid was determined in biological samples [4][5][6][7][8][9][10][11][12][13]16,[19][20][21][22][24][25][26][27][28][29][30][31][32][33][34][35][36][38][39][40]. Only a few studies report the determination of valproic acid in pharmaceutical preparations [14,17,20,23,35,37,41,42]. From the analytical point of view, the methods that do not require derivatization of valproic acid [6][7][8][9][10][11][16][17][18][19][20]…”

“…Only a few studies report the determination of valproic acid in pharmaceutical preparations [14,17,20,23,35,37,41,42]. From the analytical point of view, the methods that do not require derivatization of valproic acid [6][7][8][9][10][11][16][17][18][19][20]22,[25][26][27][28][29][33][34][35][36][37][38][39][40][41][42] seem to be important because it shortens the time of the analysis. However, very often, pre-chromatographic derivatization of valproic acid allows the obtainment of lower values of its limit of detection.…”

Ag Nanoislands Modified Carbon Fiber Nanostructure: A Versatile and Ultrasensitive Surface-Enhanced Raman Scattering Platform for Antiepileptic Drug Detection

“…Figure 11a shows the Raman spectra of sodium valproate with different concentrations ranged from 1 to 10 3 ng/µL, the characteristic peaks centered at 1350 cm −1 and 1600 cm −1 can be clearly observed. The LOD for sodium valproate was 1 ng/µL which was far lower than that detected by reversed-phase HPLC method [48]. Meanwhile, under logarithmic operation, the linear modified relationship curves of Raman signal intensity to sodium valproate concentration at 1350 cm −1 and 1600 cm −1 are displayed in Figure 11a 1 , which provides a reference for the detection of sodium valproate solution with unknown concentration.…”