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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 t...
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Context 1
... [MP], methyl 4-hydroxybenzoate (Fig. 1a), has a molecular weight of 152.156 g/mol. propylparaben [PP], chemically is Propyl 4-hydroxybenzoate (Fig. 1b), with a molecular weight of 180.2 g/mol [1]. Both MP and PP are members of Parabens group which are commonly used as preservatives in pharmaceutical formulation, as well as food and cosmetic products due to their anti-fungal ...
Context 2
... [MP], methyl 4-hydroxybenzoate (Fig. 1a), has a molecular weight of 152.156 g/mol. propylparaben [PP], chemically is Propyl 4-hydroxybenzoate (Fig. 1b), with a molecular weight of 180.2 g/mol [1]. Both MP and PP are members of Parabens group which are commonly used as preservatives in pharmaceutical formulation, as well as food and cosmetic products due to their anti-fungal and antibacterial activity [2,3]. The parabens proved efficiency over a wide pH range [4]. Addition of ...
Context 3
... valproate [VLP] is chemically sodium-2-propyl pentanoate (Fig. 1c) [1]. It is the first line drug used in the treatment of primary generalized, partial, and myoclonic seizures. VLP mode of action is to increase the synthesis and decrease the metabolism of gammaaminobutyric acid, thus stabilizing the electrical activity in the brain [10,11] ORIGINAL RESEARCH PAPER in both USP and BP which have adopted ...
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A simple, specific, accurate, precise , rapid, robust and selective stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for assay and related substances and validated for quantification of Crisaborole with its excipients in its topical dosage form. Forced degradation study is done to determi...
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... Up to date no validated analytical method for the determination of OXC, methyl paraben, propyl paraben and potassium sorbate in oral suspension formulation was available in literature. Here, RP-HPLC method was used because of its unique characters, as it is environmentally and economically benign than other methods [25][26][27][28][29][30]. Up to date in 2021 Kwabena F. et al. discussed common chromatographic principles, requirements and/or conditions for HPLC as applied to assay of oxacarbazepine and 27 antiepileptic drugs in six biological matrices [31]. ...
A simple, sensitive, selective, accurate and precise method was developed and fully validated for
determination of oxcarbazepine (OXC) in presence of their preservatives and determination of oxcar-
bazepine (OXC) in human plasma. A reversed phase liquid chromatography (RP-HPLC) with UV
detection techniques were applied for separation and quantification of studied drug OXC. Successful
separation of the drug from methyl paraben (M.P.), propyl paraben (P.P.) and potassium sorbate (P.ST.)
was achieved on a Kromasil C18 column (5 μm particle size, pore size 300 Å, l 3 I.D. 250 3 4.6 mm).
The mobile phase that contain aqueous 0.05M potassium dihydrogen phosphate buffer (pH 7):
acetonitrile, (50: 50, %v/v). The method was linear over concentration ranges 5.0–50 μg mL�1 for OXC.
Bioanalytical validation of the developed method was carried out according to US-FDA guidelines and
revealed a good linear relations over a range of (5.0–50), (0.5–10), (0.05–0.15), and (1.0–10) μg mL�1 for
OXC, M.P, P.P, and P.ST, respectively, with a correlation coefficient (R2) of more than 0.999. Limit of
detection (LOD) were 1.15, 0.03, 0.01 and 0.04 μg mL�1 for OXC, M.P, P.P, and P.ST, respectively,
Intra and inter-day precisions, calculated as percentage relative standard deviation (% RSD), were lower
than 2.0%. The developed method can be applied for routine drug analysis, therapeutic drug monitoring
and bioequivalence studies through the analysis of plasma samples taken from blood bank
... [9]. There are few studies were reported for quantitation of Pioglitazone alone and combined with other drugs which includes bioanalytical methods using human plasma [10,11] (12,13) and rat plasma [12], RP-HPLC [13- Here, RP-HPLC method was used due to its unique characters, as it is environmentally and economically simpler than other methods [41][42][43][44][45][46][47][48][49][50] ...
... 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]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. ...
... 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]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. ...
Determination of valproic acid in the drug was carried out on the aluminum silica gel 60F254 plates and using acetone–water–chloroform–ethanol–ammonia at a volume ratio of 30:1:8:5:11 as the mobile phase, respectively. Two methods of detection of valproic acid were used. The first was a 2% aqueous CuSO4×5H2O solution, and the second was a 2′,7′-dichlorofluorescein-aluminum chloride-iron (III) chloride system. The applied TLC-densitometric method is selective, linear, accurate, precise, and robust, regardless of the visualizing reagent used for the determination of valproic acid in Convulex capsules. It has low limits of detection (LOD) and limits of quantification (LOQ), which are equal to 5.8 μg/spot and 17.4 μg/spot using a 2% aqueous CuSO4×5H2O solution as visualizing agent and also 0.32 μg/spot and 0.97 μg/spot using a 2′,7′-dichlorofluorescein-aluminum chloride-iron (III) chloride system as visualizing reagent, respectively. The described analytical method can additionally be used to study the identity of valproic acid in a pharmaceutical preparation. The linearity range was found to be 20.00–80.00 μg/spot and 1.00–2.00 μg/spot for valproic acid detected on chromatographic plates using a 2% aqueous CuSO4×5H2O solution and the 2′,7′-dichlorofluorescein-aluminum chloride-iron (III) chloride system, respectively. A coefficient of variation that was less than 3% confirms the satisfactory accuracy and precision of the proposed method. The results of the assay of valproic acid equal 96.2% and 97.0% in relation to the label claim that valproic acid fulfill pharmacopoeial requirements. The developed TLC-densitometric method can be suitable for the routine analysis of valproic acid in pharmaceutical formulations. The proposed TLC-densitometry may be an alternative method to the modern high-performance liquid chromatography and square wave voltammetry in the control of above-mentioned substances, and it can be applied when other analytical techniques is not affordable in the laboratory.
... 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. ...
A high-efficiency surface-enhanced Raman scattering (SERS) detection method with ultra-high sensitivity has been widely applied in drug component detection to optimize the product quality verification standards. Herein, a controllable strategy of sputtering Ag nanoislands on carbon fiber (C-fiber) via magnetron sputtering technology was proposed to fabricate a versatile Ag-C-fiber SERS active substrate. A wide range of multi-level electromagnetic enhancement “hot spots” distributed on Ag-C-fiber nanostructures can efficiently amplify Raman signals and the experimental enhancement factor (EEF) value was 3.871 × 106. Furthermore, substantial “hot spots” of large-scale distribution guaranteed the superior reproducibility of Raman signal with relative standard deviation (RSD) values less than 12.97%. Limit of detection (LOD) results indicated that when crystal violet (CV) is employed as probe molecule, the LOD was located at 1 × 10−13 M. By virtue of ultra-sensitivity and good flexibility of the Ag-C-fiber nanotemplate, Raman signals of two kinds of antiepileptic drugs called levetiracetam and sodium valproate were successfully obtained using an SERS-based spectral method. The Ag-C-fiber SERS detection platform demonstrated a good linear response (R2 = 0.97486) in sensing sodium valproate concentrations in the range of 1 × 103 ng/μL−1–1 ng/μL. We believe that this reliable strategy has potential application for trace detection and rapid screening of antiepileptic drugs in the clinic.
A simple, sensitive, selective, accurate and precise method was developed and fully validated for determination of oxcarbazepine (OXC) in presence of their preservatives and determination of oxcarbazepine (OXC) in human plasma. A reversed phase liquid chromatography (RP-HPLC) with UV detection techniques were applied for separation and quantification of studied drug OXC. Successful separation of the drug from methyl paraben (M.P.), propyl paraben (P.P.) and potassium sorbate (P.ST.) was achieved on a Kromasil C18 column (5 µm particle size, pore size 300 Å, L × I.D. 250 mm × 4.6 mm). The mobile system that contain aqueous 0.05M potassium dihydrogen phosphate buffer (pH 7): acetonitrile, (50: 50, %v/v). The method was linear over concentration ranges 5.0–50 µg/mL for OXC. Bioanalytical validation of the developed method was carried out according to US-FDA guidelines. The developed method can be applied for routine drug analysis, therapeutic drug monitoring and bioequivalence studies through the analysis of plasma samples taken from blood bank.
