Liquid chromatography and mass spectrometric studies of gilteritinib fumarate and characterization of its major degradation products by NMR.

Gilteritinib fumarate (GTB) is an anti-cancer drug belonging to the class of tyrosine kinase inhibitors used for the treatment of acute myeloid leukemia. It has been designated as an orphan drug by the US Food and Drug Administration (US FDA). The present research focused on carrying out the forced degradation studies of GTB and developing a UHPLC-PDA stability indicating method capable of separating GTB and its degradation products.

Organ-Specific Metabolomics of Aerial Parts of Melochia corchorifolia for Antibiofilm and Wound Healing Activities.

Melochia corchorifolia is a well-known perennial herb and has been used in traditional medicine for the treatment of a wide number of diseases. However, the phytochemical investigation in the different organs of the M. corchorifolia was poorly understood.

LC-PDA-QTof-MS characterization of the stress degradation products of Zanubrutinib: A novel BTK inhibitor.

Zanubrutinib (ZAN) is an orally administered anti-cancer medication used for the treatment of Mantle cell lymphoma. Recently, it has also been approved by FDA for the treatment of chronic lymphocytic leukemia. Determination of impurities formed in drug substances/products as a result of manufacturing or storage forms an important aspect of drug life cycle management.

Application of online liquid chromatography/quadrupole time-of-flight electrospray ionization tandem mass spectrometry for structural characterization of linagliptin degradation products and related impurities.

Rationale: Linagliptin is a drug used for the management of type 2 diabetes, which is a leading cause of global ill health and mortality. Impurities can affect the quality and safety of drug products and eventually may affect human health. A robust, sensitive and reliable analytical method is required to detect, characterize, quantify and control the presence of impurities in finished pharmaceutical products such as linagliptin.

Dramatic improvement in pharmacokinetic and pharmacodynamic effects of sustain release curcumin microparticles demonstrated in experimental type 1 diabetes model.

Curcumin (cur) is a well known plant flavonoid with pleiotropic pharmacological activities. However, due to its poor bioavailability those therapeutic benefits are still out of reach for patient community. The main aim of our study was to prepare sustained release cur microparticles (CuMPs) with Poly (lactic-co-glycolic acid) (PLGA), an FDA approved biodegradable polymer and to assess their pharmacological potential in multiple low doses streptozotocin (MLD-STZ) induced type 1 diabetes mellitus (T1DM).

Sustained-Release Curcumin Microparticles for Effective Prophylactic Treatment of Exocrine Dysfunction of Pancreas: A Preclinical Study on Cerulein-Induced Acute Pancreatitis.

Acute pancreatitis (AP) is a serious inflammatory disorder of the pancreas with considerable mortality. The clinical therapy is hampered due to lack of any approved drug for AP. In this study, we developed curcumin (cur)-loaded poly (lactic-co-glycolic acid) cur microparticles (CuMPs) for sustained release.

Identification of degradation products of saquinavir mesylate by ultra-high-performance liquid chromatography/electrospray ionization quadrupole time-of-flight tandem mass spectrometry and its application to quality control.

Rationale: Saquinavir mesylate (SQM) is an antiviral drug used for the treatment of HIV infections. The identification and characterization of all degradation products are essential for achieving the quality in pharmaceutical product development and also for patient safety.

Methods: The drug was subjected to hydrolytic (HCl, NaOH and water), oxidative (H O ), photolytic (UV and fluorescence light) and thermal (dry heat) forced degradation conditions as per ICH guidelines.

Study on the forced degradation behaviour of ledipasvir: Identification of major degradation products using LC-QTOF-MS/MS and NMR.

Ledipasvir, a novel NS5A inhibitor is used in the management of hepatitis C virus infections. The drug was subjected to forced degradation studies as per the conditions prescribed in ICH Q1 (R2) guideline. Ledipasvir degraded in hydrolytic (acid, alkaline and neutral) and oxidative stress conditions.

LC-ESI-MS/MS evaluation of forced degradation behaviour of silodosin: In vitro anti cancer activity evaluation of silodosin and major degradation products.

Silodosin (SLD) a novel α1-adrenoceptor antagonist was subjected to forced degradation involving hydrolysis (acidic, alkaline and neutral), oxidative, photolysis and thermal stress, as per ICH specified conditions. The drug underwent significant degradation under hydrolytic (acidic, alkaline and neutral) and oxidative stress conditions whereas, it was found to be stable under other stress conditions. A rapid, precise, accurate and robust chromatographic method for the separation of the drug and its degradation products (DPs) was developed on a Fortis C analytical column (150×4.

Characterization of forced degradation products and in silico toxicity prediction of Sofosbuvir: A novel HCV NS5B polymerase inhibitor.

Sofosbuvir is a direct acting antiviral medication used to treat Hepatitis C viral infection. The present study focuses on the degradation behavior of the drug under various stress conditions (hydrolysis, oxidative, thermal and photolytic) as per International Conference on Harmonization (ICH Q1A (R2)) guidelines. A high performance liquid chromatographic system (HPLC) was used to develop a selective, precise and accurate method for separating all the degradation products.

Liquid chromatography/tandem mass spectrometry study of forced degradation of azilsartan medoxomil potassium.

Rationale: Azilsartan medoxomil potassium (AZM) is a new antihypertensive drug introduced in the year 2011. The presence of degradation products not only affects the quality, but also the safety aspects of the drug. Thus, it is essential to develop an efficient analytical method which could be useful to selectively separate and identify the degradation products of azilsartan medoxomil potassium.