HPLC-DAD approach for determination of pyridoxine HCl and doxylamine succinate in pure and pharmaceutical dosage forms: A green stability-indicating assay method

Abstract

The environmental impact of analytical procedures is a major concern nowadays. As a result, scientists are now working to reduce the adverseenvironmental impact of chemicals and solvents. Stability testing is an important stage in the pharmaceutical industry because it determines how a drug product's quality changes over time as a result of environmental and laboratory conditions. This study demonstrates the use of green reversed phase (RP-HPLC) to determine pyridoxine HCl (PYR) and doxylamine succinate (DOX) in the presence of DOX oxidative degradation product (DOX DEG). DOX DEG was identified by using (LC-MS). The chromatographic separation was achieved using a mobile phase consisting of ethanol and 0.01 M phosphate buffer pH = 5.0 (10: 90, v/v) with isocratic elution, pumped at 1.0 mL/min on an Xterra C18 column (100 mm × 4.6 mm × 5 m). DAD was used for detection at 254.0 nm and the retention times for PYR, DOX and DOX DEG were 1.41 min, 5.89 min, and 7.36 min, respectively. This procedure was validover linearity ranges of 10.00–120.00 μg/mL and 5.00–100.00 μg/mL, with mean percentage recoveries100.09 ± 0.949 and 100.29 ± 0.519 for PYR and DOX, respectively. The presented chromatographic method was fully validated in accordance with ICH requirements and was statistically compared with those of the reported method and there was no significant difference between them. The proposed approach was shown to be more eco -friendly in terms of the use of hazardous chemicals and solvents, energy consumption, and waste generation than the reported one.