Chromatographic impurity profile assessment of dual action binary combination: Ecological analysis with comparative statistics

Abstract

The level of impurities in drug substances effects on safety of finished product so it must be carefully monitored during the whole medication manufacturing. The combination of paracetamol (PAR) and hyoscine N- butylbromide (HYO) has analgesic and antispasmodic action. In this research, PAR and HYO were determined using green HPLC in the presence of impurities (P-aminophenol (PAP), P-nitrophenol (PNP), and P-chloroacetanilide (PCA)) as PAR impurities. These toxic impurities were successfully separated along with additional quantification. The optimum chromatographic separation was achieved by using Zorbax® Eclipse XDB column C18 (250 mm 4.6 mm, 5 μm) as the stationary phase and acetonitrile:0.01 M phosphate buffer (pH = 5.0) at a ratio of 30:70 v/v as the mobile phase with isocratic elution, pumped at 1.5 mL/min. A UV lamp was used for detection at 210.0 nm. The retention times for PAP, PAR, HYO, PNP, and PCA were 1.35, 1.95, 3.52, 7.07, and 8.47 min, respectively. This method was reliable for linearity ranges of 10.00–300.00 μg/mL for PAR, 5.00–50.00 μg/mL for HYO and 5.00–50.00 μg/mL for the three impurities. Student's F-test and t-test method was used in the statistical comparison between established and reported methods. The result found there was statistically indistinguishable after being fully validated in accordance with ICH requirements. The proposed approach was demonstrated to be more environmentally friendly than the reported one in terms of the use of potentially harmful chemicals, energy consumption, and waste generation. In addition, the established technique is suitable for impurity profiling while the reported one is not so.