Multi-dimensional liquid chromatography (MD-LC) continues to gain in popularity for applications where conventional one-dimensional liquid chromatography is insufficient to solve the analytical problem at hand. In this review we have focused on articles published in the years 2019 to early 2023 and look for trends using our previous review published in 2018 as a baseline. We have also explored usage patterns related to involvement of industrial laboratories in the published research. The two major areas of technical development have been continued work on modulation strategies that help mitigate problems associated with mobile phase mismatch when coupling complementary separation mechanisms, and development of computer-aided method development strategies. Progress in these areas is making 2D-LC easier to use, and it appears that this is translating to a shift toward more involvement by industrial laboratories. Indeed, over 34% of the more than 200 publications on 2D-LC in the last four years have had at least one-industry affiliated author. A recent inter-laboratory comparison study focused on the performance of a sophisticated multi-stage, multi-dimensional separation for therapeutic protein characterization is an exemplary indication of the increasing investment of industrial laboratories to MD-LC, and we expect this trend to continue for the foreseeable future. 

Recent trends in two-dimensional liquid chromatography

The purpose of this study was to investigate the potential clinical relevance of estimating the apparent clearance (CL/F) of atorvastatin through population pharmacokinetic (PopPK) modeling with samples collected in a real-life setting in a cohort of ambulatory patients at risk of cardiovascular disease by using an opportunistic sampling strategy easily accessible in clinical routine. A total of 132 pharmacokinetic (PK) samples at a maximum of three visits were collected in the 70 included patients. The effects of demographic, genetic, and clinical covariates were also considered. With the collected data, we developed a two-compartment PopPK model that allowed estimating atorvastatin CL/F relatively precisely and considering the genotype of the patient for SLCO1B1 c.521T>C single-nucleotide polymorphism (SNP). Our results indicate that the estimation of the CL/F of atorvastatin through our PopPK model might help in identifying patients at risk of myalgia. Indeed, we showed that a patient presenting a CL/F lower than 414.67 L h-1 is at risk of suffering from muscle discomfort. We also observed that the CL/F was correlated with the efficacy outcomes, suggesting that a higher CL/F is associated with a better drug efficacy (i.e., a greater decrease in total and LDL-cholesterol levels). In conclusion, our study demonstrates that PopPK modeling can be useful in daily clinics to estimate a patient' atorvastatin clearance. Notifying the clinician with this information can help in identifying patients at risk of myalgia and gives indication about the potential responsiveness to atorvastatin therapy.

Atorvastatin population pharmacokinetics in a real-life setting: Influence of genetic polymorphisms and association with clinical response.

The aim of the study was to evaluate the reference range of amisulpride for Chinese patients with schizophrenia and to assess its possible influencing factors based on therapeutic drug monitoring information. The relative adverse reactions of patients induced by amisulpride were also systematically investigated. A total of 425 patients with schizophrenia were assessed, including Positive and Negative Syndrome Scales, Treatment Emergent Symptom Scale, blood routine examination, hepatorenal function, lipids, hormones, as well as myocardial enzymes at baseline, and following treatment with amisulpride for 8 weeks. The steady-state plasma concentration of amisulpride was assayed using two-dimensional liquid chromatography. At the same dose, the amisulpride plasma concentration of patients combined with clozapine was higher than that without clozapine. The therapeutic reference range of amisulpride can be defined as 230.3–527.1 ng/ml for Chinese patients with schizophrenia. The potential side effects appear to be associated with significantly increased levels of LDH, CK, creatine kinase isoenzyme (CK-MB), TC and decreased level of E2, relative to the amisulpride plasma concentration. These findings could provide individualized medication and reduce the adverse effects of amisulpride for Chinese patients with schizophrenia. 

Amisulpride steady-state plasma concentration and adverse reactions in patients with schizophrenia: a study based on therapeutic drug monitoring data

The aim of the study was to evaluate the reference range of amisulpride for Chinese patients with schizophrenia and to assess its possible influencing factors based on therapeutic drug monitoring information. The relative adverse reactions of patients induced by amisulpride were also systematically investigated. A total of 425 patients with schizophrenia were assessed, including Positive and Negative Syndrome Scales, Treatment Emergent Symptom Scale, blood routine examination, hepatorenal function, lipids, hormones, as well as myocardial enzymes at baseline, and following treatment with amisulpride for 8 weeks. The steady-state plasma concentration of amisulpride was assayed using two-dimensional liquid chromatography. At the same dose, the amisulpride plasma concentration of patients combined with clozapine was higher than that without clozapine. The therapeutic reference range of amisulpride can be defined as 230.3–527.1 ng/ml for Chinese patients with schizophrenia. The potential side effects appear to be associated with significantly increased levels of LDH, CK, creatine kinase isoenzyme (CK-MB), TC and decreased level of E2, relative to the amisulpride plasma concentration. These findings could provide individualized medication and reduce the adverse effects of amisulpride for Chinese patients with schizophrenia.

Two-dimensional liquid chromatography (2D-LC), and in particular comprehensive two-dimensional liquid chromatography (LC×LC), offers increased peak capacity, resolution and selectivity compared to one-dimensional liquid chromatography. It is commonly accepted that the technique produces the best results when the separation mechanisms in the two dimensions are completely orthogonal; however, the use of similar separation mechanisms in both dimensions has been gaining popularity as it helps avoid difficulties related to mobile phase incompatibility and poor column efficiency. The remarkable advantages of using reversed phase in both dimensions (RPLC×RPLC) over other separation mechanisms made it a promising technique in the separation of complex samples. This review discusses some physical and practical considerations in method development for 2D-LC involving the use of RP in both dimensions. In addition, an extensive overview is presented of different applications that relied on RPLC×RPLC and 2D-LC with reversed phase column combinations to separate components of complex samples in different fields including food analysis, natural product analysis, environmental analysis, proteomics, lipidomics and metabolomics. 

Two-dimensional liquid chromatography with reversed phase in both dimensions: A review.

A novel and sensitive heart-cutting two-dimensional liquid chromatography with ultraviolet detection method (2D-LC-UV) was developed and validated for determination of amisulpride in human plasma. The 2D-LC system consists of a first dimensional (1 D) LC column and a middle transfer column as well as a second-dimensional (2 D) LC column. After simple protein precipitation, the sample was directly injected into the introduction valve of the 2D-LC system. The 1 D column, playing a role of primary separation and preconcentration for complex plasma matrices, transferred the targets to the intermediate column. Following capture of targets on the middle column online, the analytes were transferred to the 2 D separation column by a six-port valve. The 2 D column, avoiding interference from the plasma matrix, completed further separation and quantification. An assistant pump was optimized for primary enrichment as well as final elution in the heart-cutting mode. The analytical time of amisulpride was 7.401 min. The accuracy was between 0.48 and 8.49%, while the intra- and inter-day precisions ranged from 0.9 to 3.1% and from 1.7% to 3.3%, respectively. The linear range of amisulpride was 48.15-2,407.59 ng/ml, while the extraction recovery was 98.7-101.3%. The strategy established in the study, which was successfully applied to therapeutic drug monitoring of amisulpride for routine clinical detection, displays high sensitivity, good repeatability, convenience and low cost.

A novel and sensitive method for determination of amisulpride in human plasma by two-dimensional liquid chromatography.

The "4 + 7" volume-based procurement is a "large group purchase" led by the Chinese government, with the aim of reducing the price of medicines by trading volume for price. Although the "4 + 7" drugs had passed the national consistency evaluation, the adverse drug reactions need to be further evaluated to ensure the safety of the "4 + 7" drugs with low prices. We aimed to analyze the occurrence characteristics and related influencing factors of adverse reactions of psychiatric drugs under the chinese drug volume-based procurement policy(4 + 7 policy), and provide references for clinical medication.137 cases of adverse drug reactions of four psychotropic drugs reported under the "4 + 7" policy in Wuxi Mental Health Center in 2020 were collected. The gender and age of patients, related "4 + 7" drugs, involving organs / systems, clinical manifestations, distribution of new / serious adverse reactions, clinic outcomes were analyzed.Among the 137 cases of adverse drug reactions, the incidence of adverse drug reactions was the highest in patients aged 61-70 (25.38%). Mainly involved 4 "4 + 7" psychiatric drugs, of which olanzapine tablets caused the most adverse reactions (54, 39.24%). The adverse reactions mainly involved the digestive system, nervous system, cardiovascular system, blood and lymphatic system, among which the digestive system was the most common (61, 44.53%). A total of 8 cases (6.16%) of new and 26 cases of serious adverse reactions were reported, all of which led to the prolongation of disease course. Except for the transient side effects, most of that were improved or cured with no death, disability or teratogenicity after stopping or reducing the dose with symptomatic treatment.Since more and more drugs will be included in "4 + 7" for clinic, clinical pharmacists should strengthen the publicity and training of the knowledge of "4 + 7" drugs, strengthen the monitoring of adverse drug reactions, and provide timely feedback to the clinic, in order to achieve early prevention, early identification, timely diagnosis and reasonable intervention of the adverse drug reactions under the context of "4 + 7" policy. 

/pdf/reevaluation-of-adverse-drug-reactions-of-psychiatric-drugs-29np2ozn.pdf

Reevaluation of adverse drug reactions of psychiatric drugs under the chinese drug volume-based procurement policy

/pdf/effect-of-pharmaceutical-care-on-the-treatment-of-2yxj2k5t.pdf

Effect of pharmaceutical care on the treatment of neuropathic pain induced by bone metastasis of liver cancer: case report

The present research was to assess the relationship between ABCB1 (G2677T/A, C3435T) polymorphisms and lipid homeostasis as well as risk of liver injury induced by atorvastatin in in-patients from China. The lipid levels (total cholesterol, high-density lipoprotein, triglycerides) as well as metabolic enzymes of hepar (glutamic-pyruvic transaminase, glutamic-oxalacetic transaminase, alkaline phosphatase, γ-glutamyl transpeptidase) in plasma for 162 patients were measured at baseline and after approximately 6 months of atorvastatin treatment. Polymorphisms of the ABCB1 gene were determined using the Snapshot technique. The associations between genetic polymorphisms and lipid levels as well as hepar indexes were evaluated at the end of medical treatment. Based on one-way ANOVA analysis, patients with the 2677GG or 3435TT genotypes showed a remarkable decrease in percentage when the level of TC was above 4.00 mmol·L-1, separately (P 2.00 mmol·L-1) (P < 0.05). The level of glutamic-pyruvic transaminase in patients with the 2677GG or 3435CC genotype displayed a significantly increase in percentage, respectively (P < 0.05). The ABCB1 G-C haplotype carriers were associated with an increased risk of AILI. The results provide evidence for clinically individualised utilisation of atorvastatin for lipid homeostasis as well as risk of induced liver injury in the Chinese population.

/pdf/association-of-abcb1-polymorphisms-with-lipid-homeostasis-4towt7adsp.pdf

Association of ABCB1 polymorphisms with lipid homeostasis and liver injury response to atorvastatin in the Chinese population.

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A novel and sensitive method for determination of amisulpride in human plasma by two-dimensional liquid chromatography.

Reevaluation of adverse drug reactions of psychiatric drugs under the chinese drug volume-based procurement policy

Effect of pharmaceutical care on the treatment of neuropathic pain induced by bone metastasis of liver cancer: case report

Association of ABCB1 polymorphisms with lipid homeostasis and liver injury response to atorvastatin in the Chinese population.