Fast and selective HPLC-DAD method for determination of pholcodine and related substances

Abstract

Quality control of pharmaceuticals requires development of fast, efficient and reliable methods for determination of active compounds as well as known and very often unknown impurities within defined concentration ranges. In this work, a simple and rapid HPLC-UV-DAD method for identification and quantification of pholcodine process related impurities and some degradation products was developed and validated. Pholcodine and its five structural analogues such as morphine, codeine, thebaine, oripavine, and papaverine were separated in less than 10 minutes using reversed phase LiChrospher C-8 column. For optimal chromatographic performance with reproducible retention times, gradient elution with 2% ammonium hydroxide in water and acetonitrile was used. The method was validated by establishing its selectivity, specifity, sensitivity, linearity, intra- and inter-day precision and robustness. All tested parameters confirmed that the method is suitable for determination of pholcodine and its five impurities in pharmaceutical drug samples. The results obtained from real sample analysis give support to the suitability of the proposed method for the purpose of quality control.

Paper-based potentiometric sensing devices modified with chemically reduced graphene oxide (CRGO) for trace level determination of pholcodine (opiate derivative drug)

“…Different analytical methods were reported for the determination of pholcodine including non-aqueous titration, 5 chemiluminescence, 4,6 UV/Vis spectrophotometry, 7 capillary gas chromatography (GC), 8,9 GC-mass spectrometry (MS), 10,11 high-performance liquid chromatography (HPLC), 12–16 ultra-performance liquid chromatography (UPLC)-MS/MS, 17 thin-layer chromatography, 18 capillary electrophoresis (CE), 19 electrochemistry 20 and 1HNMR-pH titration. 21…”

“…So, it appears to be devoid of addiction liability in man. 4 Different analytical methods were reported for the determination of pholcodine including non-aqueous titration, 5 chemiluminescence, 4,6 UV/Vis spectrophotometry, 7 capillary gas chromatography (GC), 8,9 GC-mass spectrometry (MS), 10,11 highperformance liquid chromatography (HPLC), [12][13][14][15][16] ultraperformance liquid chromatography (UPLC)-MS/MS, 17 thinlayer chromatography, 18 capillary electrophoresis (CE), 19 electrochemistry 20 and 1HNMR-pH titration. 21 The use of electrochemical sensors and especially potentiometric sensors has become greatly expanded and now occupies a large part in different applications such as pharmaceutical, environmental and biomedical analysis.…”

All-Solid-State Potentiometric Ion-Sensors Based on Tailored Imprinted Polymers for Pholcodine Determination

“…It has been shown to stimulate the production of IgE antibodies to QAI sensitization properties and thus is an alternative source for neuromuscular blocking agent (NMBA) sensitization. Different methodologies for pholcodine quantification have been reported, including nonaqueous titration [ 4 ], chemiluminescence spectrometry [ 5 , 6 ], absorption spectrophotometry [ 7 ], gas chromatography (GC) [ 8 , 9 , 10 , 11 ], high-performance liquid chromatography (HPLC) [ 12 , 13 , 14 , 15 , 16 , 17 ], thin-layer chromatography [ 18 ], capillary electrophoresis (CE) [ 19 ], electrochemistry [ 20 ], and 1 HNMR-pH titration [ 21 ]. The use of electrochemical sensors, especially potential measuring sensors, has expanded greatly and now covers a wide application range in various fields [ 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 ].…”

Determination of pholcodine in syrups and human plasma using the chemiluminescence system of tris(1,10 phenanthroline)ruthenium(II) and acidic Ce(IV)

“…Various methods using different detection systems have been employed for the determination of pholcodine including capillary gas chromatography (GC), GC‐mass spectrometry (MS), capillary electrophoresis (CE), high performance liquid chromatography (HPLC), ultra performance liquid chromatography (UPLC)‐MS/MS, electrochemistry, 1 HNMR‐pH titration and chemiluminescence (CL) analysis by microemulsions…”