High-Performance Liquid Chromatographic Determination of Pantoprazole and Its Main Impurities in Pharmaceuticals

Abstract

An RP-HPLC method for simultaneous separation and quantification of pantoprazole and its five main impurities in pharmaceutical formulations was developed and validated. The separation was accomplished on a Zorbax Eclipse XDB C18 column (5 m particle size, 150 4.6 mm id) using a gradient with mobile phase A [bufferacetonitrile (70 + 30, v/v)], and mobile phase B [bufferacetonitrile (30 + 70, v/v)]. The buffer was 0.01 M ammonium acetate solution with addition of 1 mL triethylamine/L of the solution, adjusted to pH 4.5 with orthophosphoric acid. The eluent flow rate was 1 mL/min, the temperature of the column was 30C, and the eluate was monitored at 290 nm. Linearity (r = 0.999), recovery (97.6105.8), RSD (0.551.90), and LOQ (0.0991.48 g/mL) were evaluated and found to be satisfactory. The proposed method can be used for simultaneous identification and quantification of the analyzed compounds in pharmaceutical formulations.

Instrumental analysis of some anti-ulcer drugs in different matrices

“…The eluate was monitored at 290 nm. [96] Stability-indicating TLC and HPLC methods were presented for simultaneous determination of mosapride and pantoprazole in pharmaceutical dosage form and plasma samples. The TLC method employed aluminum TLC plates precoated with silica gel as the stationary phase and ethyl acetate: methanol: toluene (4: 1: 2, v/v/v) as the mobile phase to give compact spots for mosapride (Rf 0.73) and pantoprazole (Rf 0.45) separated from their degradation products; the chromatogram was scanned at 276 nm.…”

Dual modulation of blue-fluorescent carbon dots for simultaneous detection of topotecan and pantoprazole

“…TOP and PNT were determined using different reported methods, such as high-performance liquid chromatography (HPLC), 8–12 spectroscopic, 13–16 and voltammetric techniques. 17–21…”

Method Development and Validation of Dimethyl Sulphate Content in Esomeprazole Magnesium Drug Substance by Gc-MS

“…Very few reports are available in the literature on the determination of DMS in Esomeprazole magnesium drug and its impurities. Some of the methods for DMS determination by different techniques [6][7][8][9][10][11][12][13][14][15] on different drug substances. The literature survey on DMS Content did not reveal analytical methods for determining dimethyl sulphate impurity in any pharmaceutical drug containing a salt form.…”