Current Pharmaceutical Analysis - Volume 16, Issue 7, 2020

This article describes and reviews the steps involved in risk assessment of the twenty-four (24) potential elemental impurities in pharmaceutical drug products, as per the permitted daily exposure limits. Screening and estimation of prescribed elemental impurities in pharmaceutical drug substances, inactive excipients and drug products by inductively coupled plasma mass spectrometry or inductively coupled plasma optic Read More

Background: Thiamphenicol belongs to the amphenicol class of antibiotic and possesses a broad-spectrum antimicrobial activity. An alternative microbiological assay for quantification of thiamphenicol in pharmaceutical formulations has not yet been reported in the literature. Objective: This study aimed to develop and validate an agar diffusion method for quantification of thiamphenicol in soft capsules. Methods: The assay w Read More

Background: Teriflunomide is an immunosuppressive agent. Immunosuppressive agents are drugs that inhibit or prevent activity of immune system. Teriflunomide was investigated as a medication for multiple sclerosis (MS). Various studies have reported the HPLC, UPLC, LC/MS methods for the estimation of teriflunomide. However, till date stability indicating HPTLC analysis method has not been reported for the estimation of teri Read More

Background: Sertraline Hydrochloride, an oral anti-depressant, has two chiral centers and its cis enantiomers and trans diasteromers are defined as related substances by United State Pharmacopoeia and British Pharmacopoeia. Introduction: A selective, stereospecific and economical high performance liquid chromatographic (HPLC) method was developed for the determination of sertraline enantiomeric forms. The HPLC-U Read More

Background and Objectives: Kang Fu Xin liquid (KFX) is an official preparation made from the ethanol extract product from P. Americana. The present quality control method cannot control the quality of the preparation well. The aim of the present study is to establish a convenient HPLC method for multicomponents determination combined with fingerprint analysis for quality control of KFX. Methods: An HPLC-DAD metho Read More

Background: Metoprolol is a selective β1-adrenergic receptor antagonist (β-blockers). It is widely used for the treatment of hypertension and other related diseases. Metoprolol can be used as a doping agent in sports, thus has been included in the list of forbidden drugs. In Iran, therapeutic drug monitoring (TDM) of β-blockers is an applied procedure in some cases. A therapeutic regimen could be easily managed by the determin Read More

Background: Clofazimine has antibacterial and leprostatic properties, which has its use in Multidrug Therapy (MDT) of leprosy. As per the FDA guidance for industry, each NDA and ANDA must include the analytical procedures necessary to ensure the identity, strength, quality, purity, and potency of the drug substance and drug product. However, it was noticed that no stability indicating method is available in the literature Read More

Introduction: Polyvinyl alcohol (PVA), a polymer, is in demand due to its usage in different applications such as pharmaceutical, biomedical and textile, paper, food industries. Methods: A new sensitive reversed phased high-pressure liquid chromatography (RP-HPLC) method with refractive index detector (RID) was developed for determination of PVA in an ophthalmic solution containing dexpanthenol and PVA as active subst Read More

Background: Abuse of drugs is associated with several medical, forensic, toxicology and social challenges. “Drugs of abuse” testing is therefore an important issue. Objective: We propose a simple CE-based method for the quantification of amphetamine, codeine and morphine after direct injection of Exhaled Breath Condensate (EBC) by the aid of simple stacking mode and an off-line pre-concentration method. Methods: Us Read More

Background: Among the existing antifungal drugs, Amphotericin B is the first drug in the treatment of systemic fungal infections. However, its large adverse reactions limit the clinical application and Liposome Amphotericin B resolves the problem. Objective: In the present study, a rapid, simple, sensitive and efficient method based on LCMS/ MS for determination of liposomal Amphotericin B in rat plasma and tissue samples using Read More

Background: Nardostachys jatamansi DC. is indigenous to the Himalayan regions of India and Tibetan plateau of China, and widely used as drugs for treating various neurological disorders, insomnia, hysteria and depressive illness. However, beyond the huge efforts to the organic components in N. jatamansi, the elemental contents have not been investigated, which are important for the quality control and biosafety evaluation Read More

Background: The main aim of the study was to develop an automated static headspace gas chromatography (SHS-GC) method for determination of dichloromethane (DCM) in ampicillin sodium by using a capillary column. Methods: SHS-GC also known as gas chromatography-headspace is the technique of choice due to its high sensitivity, excellent separation abilities, low limit of detection and simplicity of the instrumentation us Read More

Introduction: Loratadine (LOR) (Fig. 1), an active H1 receptor antagonist, is often used in the treatment of allergic disorders such as seasonal allergies and skin rash [1]. LOR was clinically approved for symptomatic relief of nasal and non-nasal symptoms of allergic rhinitis in children ≥2years. Materials and Methods: An adapted method of liquid chromatography-mass spectrometry (LC/MS/MS) was developed and valid Read More

Background: In some cases, lifestyle changes are not enough to keep type 2 diabetes under control, so there are several medications that may help. Metformin can lower your blood sugar levels, Glimepiride makes more insulin, whereas Empagliflozin prevents the kidneys from reabsorbing sugar into the blood and sending it out in the urine. Methods: Mean centering, double divisor, ratio spectra-zero crossing, and successive Read More

Background: Esculin (ESCN) is used in the pharmaceutical industry with intravenous effect, stimulant and anti-inflammatory capillaries, like vitamin P. It is a significant component of many anti-inflammatory remedies such as esqusan, esflazid and anavenol [14]. It is also found in numerous other remedies available in the market such as proctosone, anustat, and ariproct. Objective: To determine experimental conditions, to elucidat Read More

Background: This study reports an easy method of a veterinary drug investigation in raw milk, based on QuECHERS extraction followed by RP-HPLC-UV analysis. Use of this benchtop system was motivated by its availability and moderate cost relatively to other sophisticated methods such as LC-MS which are more efficient. Methods: This developed method has been optimized and then after validation according to EU legislation, i Read More

Background: Clarithromycin is widely used for infections of helicobacter pylori. Clarithromycin belongs to polymorphic drug. Crystalline state changes of clarithromycin in sustained release tablets were found. Objective: The aim of this study was to find the influential factor of the crystal transition of clarithromycin in preparation process of sustained-release tablets and to investigate the possible interactions between the c Read More

Introduction: In this study, we used UPLC-MS/MS to detect shanzhiside methylester in rat plasma, and investigated its pharmacokinetics in rats. Materials and Methods: Diazepam was utilized as an internal standard (IS), and acetonitrile precipitation method was used to process the plasma samples. Chromatographic separation was achieved using a UPLC BEH C18 column using mobile phase of methanol-0.1 % formic acid w Read More

Background: Sequential injection chromatography (SIC) with monolithic column has been proposed with potential benefits for separation and quantification. Objective: To utilize SIC to develop a new assay method for the separation and quantification of some phenothiazines (promethazine, chlorpromazine and perphenazine) in human urine and synthetic pharmaceutical formulations. Methods: The 32 full-factorial design was Read More

Background: The present study was focused on the development of HPLC method for purity testing of sofosbuvir by the Design of Experiments and determination of the activation energy of hydrolytic degradation reactions of sofosbuvir using HPLC based on the kinetics of sofosbuvir degradation. Methods: Following four factors for the Design of Experiments were selected, stationary phase, an organic modifier of the Read More