Current Pharmaceutical Analysis - Volume 17, Issue 7, 2021

Background: Antibody Drug Conjugates (ADCs) are complex hybrid molecules comprised of a monoclonal antibody (mAb) connected to a small molecule drug through a linker. The key step in the production of ADCs is bringing together the protein in an aqueous buffer with a hydrophobic small molecule in order to achieve conjugation of the molecules. This step involves dissolving the small molecule portion of the compou Read More

Background: Banlangen granules are broad-spectrum effective antiviral drugs, and have a large clinical demand in China. Free amino acid is one of the main antiviral active ingredients of Banlangen granules. The pre-processing of samples by the existing pre-column derivatization reversed- HPLC method is complicated. Therefore, the determination of free amino acids (AAs) by underivatized ion-pair HPLC-CAD is advantageo Read More

Objective: To develop a rapid ultra-performance liquid chromatographic (UHPLC)-UV method for vancomycin determination in human serum for therapeutic drug monitoring (TDM). Methods: Human serum samples were precipitated with 10% perchloric acid, and the supernatant after centrifugation was analyzed on an ACQUITY UHPLC BEH C18 column (2.1 × 50mm, 1.7 μm) via gradient elution with a flow rate at 0.3 m Read More

Background: Mezlocillin is off-label used for the treatment of respiratory infections in children. Therapeutic Drug Monitoring (TDM) data are also limited in children. A sensitive Liquid chromatography- tandem mass spectrometry (LC–MS/MS) method adapted to children was developed and validated for the determination of mezlocillin plasma concentration in the present study. Methods: Mezlocillin, extracted from a volume Read More

Introduction: OC26, an ortho-aryl chalcone compound, shows excellent antitumor activity in vitro and vivo. However, the pharmacokinetic characteristics of OC26 have not been comprehensively reported. It is essential to investigate the correlation of pharmacological response. Objective: To further explore OC26, this study aims to develop an ultra-performance liquid chromatography- tandem mass spectrometri Read More

Background: High-Performance Liquid Chromatography (HPLC) method has been used to detect related impurities of perampanel. However, the detection of impurities is incomplete, and the limits of quantification and detection are high. A sensitive, reliable method is badly needed to be developed and applied for impurity detection of perampanel bulk drug. Objective: Methodologies utilising HPLC and Gas Chromatograph Read More

Background: Indobufen is a drug that hinders the aggregation of platelets by reversibly repressing the cyclooxygenase enzyme, further bringing about diminished thromboxane production. During quality control of indobufen tablets, an unknown impurity was detected. Objective: To characterize an unknown impurity in indobufen tablets. Methods: A new method compatible with mass spectrometry detection was set u Read More

Background: Phospholipids are widely used in food and pharmaceutical industry as functional excipients. In spite of the many analytical methods reported, there are very limited reports concerning systematic research and comparison of phospholipid excipients. Objective: To present a comprehensive evaluation of commercial natural phospholipid excipients (CNPEs). Methods: Seventeen batches of CNPEs from five man Read More

Introduction: Diquat is a fast-acting contact herbicide and plant dehydrating agent. The oral lethal dose 50 (LD50) of diquat in mice is about 125 mg/kg. The purpose of this study is to research the metabolomics in mouse plasma after acute diquat poisoning. Methods: The mice were divided into two groups (the control group and acute diquat poisoning group). The control group was given normal saline by gavage. The acute Read More

Objective: To systematically characterize the impurity profile in Daptomycin raw material by 2 Dimensional LC/MSn. Methods: The target impurity was separated by first Dimensional HPLC and enriched by a 500μl loop, then desalted using the on-line second Dimensional HPLC and analyzed by MS detector in positive mode. Their structures were characterized based on the degradation mechanism and mass fragmentation regul Read More

Background: The number of validated quantification methods for rifampicin, a prototypical Oatp inhibitor, in biological rat samples is limited. Objective: This study was conducted to validate a modified reversed-phase liquid chromatographic method for the determination of rifampicin in rat liver tissue according to the current ICH M10 Bioanalytical Method Validation Draft Guideline (2019) for application to samples of in si Read More

Background: Buprenorphine is quite common in the illicit market. Buprenorphinecontaining drug abuse is frequently encountered in patients. The analysis methods used to determine the abuse of buprenorphine and norbuprenorphine are important for forensic science. Buprenorphine is metabolized to norbuprenorphine by the liver. Objective: Therefore, the determination of buprenorphine and norbuprenorphine in urine Read More

Background: In view of the current FDA standardization and product quality control criteria, Quality by design approach for analytical methods is gaining importance to develop a robust analytical method. A new Quality by Design approach by RP-HPLC was developed and validated for the quantification and purification of Tadalafil hydrochloride and its tablet formulations. Objective: The objective of the study was to develop Read More

Background: Diazepam belongs to the group of 1,4-benzodiapines. It is used for the treatment of anxiety, convulsions and as muscle relaxants. The presence of a 4,5-azomethine group enables its electrochemical detection. Introduction: A screen-printed electrode modified with antimony film was used for the determination of diazepam in pharmaceutical preparations. Methods: Electrode modification was done by ex-situ depo Read More