Abstract
AbstractA stability-indicating hybrid micelle liquid chromatography accompanied by UV detection was developed for the simultaneous analysis of either paracetamol (PCA) or pseudoephedrine hydrochloride (PSU) with their synthetic impurities. Mixture I contains PCA withp-amino phenol andp-nitro phenol, while mixture II involves the estimation of PSU with benzaldehyde and benzoic acid. Both mixtures were separated using a C18 column that was thermostatically maintained at 40°C and operating under a flow rate of 1.5 mL/min, applying UV detection at 240 nm for mixture I and 220 nm for mixture II. In both cases, the mobile phase consisted of 0.1 M sodium dodecyl sulfate, acetonitrile, and triethylamine (90:10:0.3, v/v/v) and adjusted to pH 4 (mixture I) or pH 3.7 (mixture II) using 2.0 MO-phosphoric acid. The proposed method was validated and successfully applied to assay different pharmaceuticals containing PCA or PSU. Moreover, the stability-indicating nature of the proposed method was proved through applying photolytic degradation procedures for PCA.
Highlights
Potency and safety of pharmaceutical compounds are two major concerns during remedial treatment
Since PCA is synthesized through an acetylation reaction between p-amino phenol (PAP) and acetic anhydride [7], PAP is, considered as a major organic impurity of PCA, where it being the starting material may be found in excess as unreacted form, or it may be present as a degradation product of PCA due to improper storage [7]
The column thermostat was maintained at 40°C through the analysis, which assisted in lowering the applied pressure resulting from the organic modifier and the high flow rate [37]
Summary
Potency and safety of pharmaceutical compounds are two major concerns during remedial treatment. Some organic impurities are formed during the synthesis of PCA, including p-amino phenol (PAP) and p-nitro phenol (PNP) (Table 1). Since PCA is synthesized through an acetylation reaction between PAP and acetic anhydride [7], PAP is, considered as a major organic impurity of PCA, where it being the starting material may be found in excess as unreacted form, or it may be present as a degradation product of PCA due to improper storage [7]. PNP may be present but in a lower extent than PAP [8] Both USP and BP specify the amount of PAP in PCA pure form to be 0.005% w/w [4,5], while its limit in the final products depends on the type of the dosage form [7]. The significance of PAP quantitation is based on the reported clinical studies of its teratogenic and nephrotoxic effects
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