Simultaneous HPLC Determination of Chlordiazepoxide and Mebeverine HCl in the Presence of Their Degradation Products and Impurities

Abstract

A simple, rapid, and sensitive RP-HPLC method was developed and validated for the simultaneous determination of chlordiazepoxide (CDO) and mebeverine HCl (MBV) in the presence of CDO impurity (2-amino-5-chlorobenzophenone, ACB) and MBV degradation product (veratric acid, VER). Separation was achieved within 9 min on a BDS Hypersil phenyl column (4.5 mm × 250 mm, 5 µm particle size) using a mobile phase consisting of acetonitrile: 0.1 M potassium dihydrogen phosphate: triethylamine (35 : 65 : 0.2, v/v/v) in an isocratic mode at a flow rate of 1 mL/min. The pH of the mobile phase was adjusted to 4.5 with orthophosphoric acid and UV detection was set at 260 nm. A complete validation procedure was conducted. The proposed method exhibited excellent linearity over the concentration ranges of 1.0–100.0, 10.0–200.0, 2.0–40.0, and 2.0–40.0 µg/mL for CDO, MBV, VER, and ACB, respectively. The proposed method was applied for the simultaneous determination of CDO and MBV in their coformulated tablets with mean percentage recoveries of 99.75 ± 0.62 and 98.61 ± 0.38, respectively. The results of the proposed method were favorably compared with those of a comparison HPLC method using Studentt-test and the variance ratioF-test. The chemical structure of MBV degradation product was ascertained by mass spectrometry and IR studies.

Method Development and Validation of Mebeverine HCL in Bulk Drugs by Rp-HPLC Method

“…[1][2][3][4][5][6][7] Stability study and quantitative determination of mebeeverine hydrochloride. [8] UV spectrophotometric method was developed for Mebeverine HCl.…”

Development and Validation of Spectrophotometric Methods for the Simultaneous Determination of Mebeverine Hydrochloride and Chlordiazepoxide in Bulk and in Dosage Form

“…Univariate spectrophotometric methods via different manipulation pathways [24] has been reported for the simultaneous determination of MEB and CHL. Besides, MEB and CHL has been determined by HPLC [25][26][27][28][29].…”