title: Simultaneous determination of paracetamol, chlorzoxazone, and related impurities 4-aminophenol, 4'-chloroacetanilide, and p-chlorophenol in pharmaceutical preparations by high-performance liquid chromatography.
abstract: This paper presents a simple, specific, and precise high-performance liquid chromatographic method for the simultaneous determination of paracetamol (PCM), chlorzoxazone (CXZ), and their related impurities in bulk raw materials and solid dosage forms. The mobile phase consisted of water-methanol-glacial acetic acid (60 + 40 + 2, v/v/v). A column containing octadecylsilane chemically bonded to porous silica particles (Spherisorb ODS 1, 25 cm x 4.6 mm, 5 microm) was used as stationary phase. Detection was performed using a variable wavelength ultraviolet-visible detector set at 272 nm for all compounds. Solutions were injected into the chromatograph under isocratic condition at a constant flow rate of 1.2 mL/min. The method was validated according to International Conference on Harmonization requirements and demonstrates good accuracy and precision and a wide linearity range. The method separates PCM, CXZ, and 3 major impurities [4-aminophenol (4AP), 4'-chloracetanilide (4CA), and p-chlorophenol (PCP)] with fair resolution in less than 15 min. The developed method is rapid and sensitive (limit of detection for 4AP, 4CA, and PCP established at 31.25, 39.06, and 65.16 ng/mL, respectively) and, therefore, suitable for quality control and stability studies of these compounds in dosage forms.
authors: Jamjoom Pharmaceuticals Co. Ltd, Quality Control, PO Box No. 6267, Jeddah 21442, Saudi Arabia. msali26@rediffmail.com
authors: Mohammed Shahid
authors: MS
authors: Ali
authors: Syed
authors: S
authors: Rafiuddin
authors: Mohsin
authors: M
authors: Ghori
authors: Aamer Roshanali
authors: AR
authors: Kahtri
mesh_terms: D000081:Acetamides / Q000032:analysis* / Q000302:isolation & purification; D000082:Acetaminophen / Q000032:analysis* / Q000302:isolation & purification; D000627:Aminophenols / Q000032:analysis* / Q000302:isolation & purification; D002733:Chlorophenols / Q000032:analysis* / Q000302:isolation & purification; D002753:Chlorzoxazone / Q000032:analysis* / Q000302:isolation & purification; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D015394:Molecular Structure; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012996:Solutions
chemical_list: D000081:Acetamides; D000627:Aminophenols; D002733:Chlorophenols; D004364:Pharmaceutical Preparations; D012996:Solutions; C013874:chloroacetamide; D000082:Acetaminophen; C029107:4-chlorophenol; D002753:Chlorzoxazone; C026729:4-aminophenol