High-Performance Liquid Chromatography-Tandem Mass Spectrometry for the Determination of Trospium Chloride in Human Plasma and Its Application in a Bioequivalence Study

Abstract

A selective, rapid, and sensitive high performance liquid chromatography-tandem mass spectrometry (HPLC-ESI-MS/MS) method was developed and validated for the quantification of trospium chloride in human plasma. With tramadol chloride as the internal standard, sample pretreatment involved a simple liquid-liquid extraction with chloroformisopropyl alcohol (40/2, v=v) of 0.5 ml plasma. The analysis was carried out on a Hypsil C 18 column (150 mm  2.1 mm, 5.0 lm) with a flow rate of 0.2 ml/min. The mobile phase was methanol-5% acetic acid-20 mM ammonium methylate (55/30/15, v/v/v). The detection was performed by a selected reaction monitoring (SRM) mode via electrospray ionization (ESI). Linear calibration curves were obtained in the concentration range of 0.2-50.0 ng/ml, with a lower limit of quantification of 0.2 ng/ml. The intra-and inter-day precision (RSD) values were below 15%. The method was successfully applied to a clinical bioequivalence study of trospium chloride in Chinese healthy volunteers following oral administration.

Novel approaches of erythrosine B as a food dye‐derived spectroscopic probe for assessing trospium chloride in raw material and dosage form

“…It reduces the contractile tone of smooth muscle by inhibiting acetylcholine at muscarinic receptors, authorizing relaxing of the detrusor and reducing uncontrolled detrusor contractions. [2] Different documented methods have been published in TPM assessment including high performance liquid chromatography (HPLC) methods, [3][4][5][6] spectrophotometric methods, [7][8][9] and electrochemical methods. [10][11][12] The British Pharmacopoeia suggested a chromatographic method for estimating of TPM using C8 column and a mobile phase containing triethylamine: phosphoric acid:water:acetonitrile (0.1:0.3:70:30, v/v).…”

“…Performing HPLC methods requires expensive organic solvents, sophisticated instruments, and a sample pretreatment process, in addition to the high cost and unavailability of MS detectors in most research laboratories. [5,6] The low sensitivity of the reported spectrophotometric methods was a drawback in the methods, in addition to using nongreen caustic diluting solvents such as NaOH or HCl. [7,9] Electrochemical processes need costly chemicals such as silver nitrate, [10,11] in addition to the required experience to conduct the study.…”

“…Different documented methods have been published in TPM assessment including high performance liquid chromatography (HPLC) methods, [ 3–6 ] spectrophotometric methods, [ 7–9 ] and electrochemical methods. [ 10–12 ] The British Pharmacopoeia suggested a chromatographic method for estimating of TPM using C8 column and a mobile phase containing triethylamine: phosphoric acid:water:acetonitrile (0.1:0.3:70:30, v/v).…”

Novel Electroanalytical Technique for Determination of Trospium Hydrochloride

“…For TRO analysis in pharmaceutical and biological samples, few analytical methods were reported in literature including high performance liquid chromatography-tandem mass spectrometry [5,6], LCMS/MS [7,8], RP-HPLC [9]. To less extent spectrophotometric [10,11], fluorimetric using RP-UFLC [12] and atomic absorption [13] techniques were found.…”

New Stability-Indicating RP-UFLC Method for Determination of Trospium Chloride in Tablet Dosage Form

“…It includes estimation of trospium in tablets by the UV spectro-photometric method, HPLC -fluorescence analysis of trospium by derivatization with benoxaprofen chloride, HPLC analysis of trospium chloride in tablets, and the LC-MS and LC-MS/MS methods for estimation of trospium in human plasma samples [4–9]. But no stability-indicating RP-UFLC method was reported until the literature survey for the determination of trospium chloride in pharmaceutical dosage form.…”