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Pharma

A

Acetylsalicyclic acid (APK #317)

Acetylsalicylic acid is very well-known as the drug Aspirin and is used to reduce pain and fever. It is also supplied under other brand names, such as Acylpyrin or Anopyrin. This application note shows the determination of impurity – salicyclic acid in the final product.

Ampicillin in human blood plasma (APK #409)

The accurate, simple, and selective HPLC/UV method has been established and validated for the determination of the antibiotic AMP as a suitable method in a cardiac surgery which does not have to be used only in cardiac surgery. The new ARION® Polar C18 column has been shown to effectively separate AMP in human blood plasma.

Analysis of Anti-infective agents (APK #557)

Anti-infectives are a class of many types of drugs that cover a broad range of infections, including antibiotics, antifungals, antiviral, and even protozoal infections. They have different mechanisms of action based on pathogens transmission and interaction with their host. Column ASTRA® allows to separate a broad spectrum of anti-infectives with a completely different chemical structure.

Analysis of drugs of abuse (APK #560)

Drug abuse has become a serious problem worldwide. Determination of drugs of abuse is important for undertanding of the needed treatment as well as for the law enforcement. The list of target compounds to be screened can number in the hundreds. This application shows a rapid analysis of the drugs of abuse belonged to different classes.

Antidiabetic drugs (APK #564)

Diabetes is a chronic condition that occurs when the body cannot produce any or enough insulin, or cannot effectively use the insulin it produces. Type 2 diabetes has attained the status of a global pandemic. Sulfonylureas represent a class of medications used in the treatment of type 2 diabetes mellitus. All sulfonylureas contain a phenyl-sulfonyl-urea structure, which exerts the hypoglycemic effect. An efficient and reliable LC/MS method has been developed for сontrol of antidiabetic
medications of sulfonylurea class glibenclamide and glimepiride.

API glucuronide by LC/MS (APK #372)

This application shows high ASTRA® HPLC column stability in the pharmacokinetic assay. API is used in hypolipidemic therapy adjusting cholesterol levels in the human body.

Avenanthramides (APK #326)

Avenanthramides (AVN) are phenolic alkaloids that are found mainly in oats. They are used in various diary supplements and dermatology products thanks to their anti-inflammatory effects and antioxidant activities.

Azithromycin (APK #329)

Azithromycin is an antibiotic used to treat many different types of infections. It belongs to a group called macrolides and has relatively broad antibacterial activity.

B

Beta Blockers (APK #371)

Beta Blockers are also known as beta-adrenergic blocking agents. They are used as a medication that reduces blood pressure.

C

Calcium gluconate in injection solution (APK #474)

Calcium is found naturally in the body and is necessary for the normal function of muscles and nerves. It is needed to make the heart work properly and for blood to clot. In injections it is used in the form of calcium gluconate salt. The presented method shows the in-process control of calcium gluconate and stabylizer calcium saccharate in injection solution.

Cardiovascular drugs (APK #559)

A gradient LC/MS method was developed for rapid determination of several classes of cardiovascular drugs such as non-cardioselective beta blockers, potassium-sparing diuretics, statins, nucleoside transport inhibitors, calcium channel blockers, ACE inhibitors, ARBs, lipid-lowering agents and anticoagulants.

Cefazolin sodium (APK #453)

Cephalosporin antibiotic cefazolin sodium is widely used in medicine practice. ARION® Polar C18 column provides perfect resolution factor and peaks symmetry according to the pharmacopoeial method for determination of cefazolin sodium.

Ceramides (APK #484)

Ceramides are a family of fatty acids molecules. They play a role in skin’s barrier function and also promote brain development and maintain cell function. They are widely used as a moisturizer in various cosmetic and personal products. The application shows a sensitive LC/MS method for fast determination of diverse group of ceramides.

Citrates in Infusion Solution (APK #370)

Citrate is a chemical stabilizer used in infusion solutions. However, infusion of citrate is responsible for a decrease of arterial blood preessure. So, it is very important to keep optimum concentration in citrate infusion.

Clonazolam (APK #381)

Xanax is an benzodiazepine alprazolam-based anxiolitic. Counterfeit Xanax may contain caffeine as a main component, as well as clonazolam and flualprazolam, both of which have a strong sedative effect, are able to cause amnesia, and belong to the group of new psychoactive drugs.

CNS agents monitoring (APK #563)

There are many different types of drugs that affect the central nervous system (CNS), including anesthetics, anticonvulsants, antiemetics, antiparkinson agents, CNS stimulants, muscle relaxants, narcotic analgesics and sedatives. Their control is important for therapeutic monitoring and in toxicologic purposes. The developed LC/MS method provides the accurate determination of a wide range of CNS agents.

Codeine phosphate (APK #466)

Control of active pharmaceutical ingredients should meet the strict requirements of pharmacopeial monographs. ARION® Plus C18 column provides perfect tailing
factor and resolution coefficient according to USP Monograph for codeine phosphate in comparison with competitive’s column.

D

Dihydrotestosterone (APK #478)

Dihydrotestosterone (DHT) is an androgenic hormone synthesized primarily in prostate. DHT plays a primary role in the formation of the male genitalia during embryogenesis and it acts as the primary androgen in the prostate and hair follicles in adulthood. In medicine it is used mainly in the treatment of low testosterone levels. ARION® Biphenyl column allows to determine DHT with sufficient tailing factor and resolution coefficient in the complex mixture of excipients in finished dosage form.

Dissolution profile pyridoxine and benfotiamine (APK #418)

The development of the HPLC method for vitamin mixtures in drug products is always challenging, taking into account the requirements of analytical methods in pharmaceutical production. Shown below is a chromatogram of dissolution profile of tablets that contain a mixture of pyridoxine hydrochloride and benfotiamine. ARION® Polar C18 column provides a perfect resolution factor and peaks symmetry in a long sequence of analysis.

E

Ergot alkaloids (APK #444)

Ergot alkaloids are mitotoxins produced by several species of fungies. Many different cereals may become contaminated with ergot alkaloids that cause poisoning in human and animals is known as ergotism. Despite on actions taken in agricultural practice for grain purification, control of the ergot alkaloids is still actual taking into account the low toxicological limits of these mitotoxins.

F

Flavonoids and their sulfated metabolites by HPLC method (APK #462)

Flavonoids have antioxidant and antiviral properties and are widely used as drugs and dietary supplements. Sulfation reaction of flavonoid compounds is part of mammalian metabolism. The presented method allows to separate parent compounds luteolin, quercetin, silychristin and their sulfated derivates in enzymatic sulfation reaction mixtures.

H

HMF in Infusion Solution (APK #369)

The levels of the degradation product, 5-hydroxymethylfurfural (5-HMF), in Dextrose Injection is an important determination in pharmaceutical formulas and pharmacokinetic studies. ASTRA® DM shows better retention for polar compounds.

Hormones receptors agents (APK #565)

Hormones are responsible for carrying out various functions in the human body. A treatment of lot of diseases is based on hormones receptor – targeted agent interaction. In this application is shown a precise lc/ms method for analysis of drugs agents finasteride, tamoxifen, used in cancer therapy, and beclomethasone, well known agent for asthma managment.

Hymecromone purity (APK #386)

Hymecromone is a drug used as a choleretic and antispasmodic medicine to treat bile.

I

Ibuprofen (APK #307)

Ibuprofen is a substance from a group of non-steroidal anti-inflammatory drugs. In order for the drug release to be targeted on the basis of pH change (gradual release for up to 30 days), binding to a polymeric carrier is used.

Ipidacrine (APK #303)

Ipidacrine is a drug inhibitor of acetylcholinesterase produced for the treatment of memory disorders caused by various diseases. This drug was first synthetized by the National Research Centre for Biologically Active Compounds (Russian Federation).

M

Melatonin (APK #551)

Melatonin is a natural compound produced by various organisms. In human body this hormone is secreted in the brain, playing a crucial role in regulating the sleep-wake cycle. In addition to its endogenous functions, it is administered as a medication in the treatment of sleep disorders, such as insomnia and various circadian rhythm sleep disorders. In this application two different ASTRA® C18-HE columns were tested according to Ph. Eur. Monograph method for melatonin. Both columns show the excellent peak symmetry in conditions of assay determination and related substances method.

O

Opioids APIs (APK #475)

Opioids can be used in medicine to treat pain and to manage withdrawal symptoms. ASTRA® Phenyl-Hexyl-HE column allows to separate the mixture of opioids with sufficient resolution coefficients in comparison to competitive’s column.

P

Penicillin impurities (APK #314)

Penicillin is well know antibiotic found by Alexander Fleming. He isolated it from the mold Penicillium notatum. The application shows better separation of impurities in pharmaceutical production.

Phenoxymethylpenicillin impurities (APK #330)

This application shows Phenoxymethylpenicillin potasium impurities analysis in accordance with Ph. Eur. monograph.

Potassium trichloroammineplatinate (II) (APK #385)

Potassium trichloroammineplatinate(II) (KTCAP) is key intermediate in the synthesis of novel platinum anticancer drugs.

Prostaglandins (APK #337)

Prostaglandin Active Pharmaceutical Ingredients (APIs) play a significant role in the bodies of humans and animals, and therefore are synthetised for use in ophthalmology, veterinary, and vascular treatment.

Q

Quinolones (APK #410)

A Quinolone antibacterials are drugs used in veterinary medicine to treat bacterial infections. The analysis of residual amounts of drugs in food is important for monitoring the quality control of products of animal origin. This application clearly shows the separation of 16 quinolones using the LC/MS technique.

R

Related substances of cefazolin sodium (APK #516)

Separation of impurities with close structure is always challenging in pharmaceutical industry due to the strict requirements to acceptance criteria of chromatographic method and low limits for impurities quantification. This application shows the method for determination of related substances of cefazolin sodium by the Ph. Eur. Monograph. ARION® Polar C18 column allows to separate all impurities according to the method.

S

Synthetic Opioid in Cleaning Validation (APK #375)

This API is a synthetic opiod with around 100 times stronger effect than morphine. This application shows API monitoring during a validation of a cleaning process at trace levels.

T

Tamsulosin hydrochloride analysis (APK #292)

Tamsulosin hydrochloride is used to treat the symptoms of an enlarged prostate. This drug is an alpha-blocker that works by relaxing the muscles in the prostate and the bladder. Tamsulosin is sold under various trade names, e.g. Flomax, Urimax, Contiflo XL, Mesir LP, Prostanil MR, Tamsin, Fokusin, etc. The application note shows the chromatogram of the determination of the tamsulosin hydrochloride content according to the proprietary method.

Thiopental impurities (APK #411)

Thiopental sodium is a medicine given intravenously to induce short duration general anaesthesia. The content of active pharmaceutical ingredients and related substances should be strictly controlled for injected drugs. This application shows a method for the simultanious determination of thiopental and related substances. ASTRA® column allows all impurities to separate according to the method and provides an accurate and robust determination of thiopental.

Triazoles (APK #414)

Triazoles are used as intermediates for API production. This application shows the separation of all triazoles in one analysis.

Tween 80 in pharmaceuticals (APK #521)

Tween 80 is used to stabilize aqueous solutions with drugs and also as an emulsifier in the pharma industry. It is also used as an additive in vaccine production. Currently it is added to Covid-19 vaccines. Column CHROMSHELL® C18-XB provides a good tailing factor for Tween 80 and excellent separation from others components in comparison to competitor’s column.

V

Vitamin D in dry blood spot (APK #325)

Vitamin D is a group of steroids that have various effects on the human body and support the immune system. This application shows LC/MS/MS separation of the hydroxylated and non-hydroxylated forms of vitamin D2 and vitamin D3. The amount of their hydroxylated forms determines the total vitamin D in a blood sample. Non-hydroxylated forms of vitamin D2 and vitamin D3 are important for food analysis. The LC/MS/MS chromatogram shows the separation of all the above mentioned analytes.

Voriconazole and Posaconazole in blood plasma (APK #347)

Voriconazole and Posaconazole are antifungal drugs that are monitored in plasma and urine. Spiked samples based on a blood plasma from blood donors at transfusion station were used in this application note.

Z

Zopiclone impurities (APK #540)

Related substances control is a mandatory test in routine specification of active pharmaceutical ingredient. Сhromatographic method should meets the strict system suitability requirements that is often challenging due to close retention times of the studied compounds. ARION® column shows a robust and precise results in control of Zopiclone related substances in a long sequense of analysis.