Current Pharmaceutical Analysis - Volume 15, Issue 7, 2019

There has been ever increasing interest in impurities present in Active Pharmaceutical Ingredient’s (API’s). Nowadays, not only purity profile but also impurity profile has become mandatory according to the various regulatory authorities. In the pharmaceutical world, an impurity is considered as an inorganic or organic material, or residual solvents other than the drug substances, or ingredients, arising out of synthesis or unwa Read More

The frequency of Type 2 Diabetes Mellitus worldwide is rising rapidly and is estimated to reach 4.4% of the world’s population or about 366 million people by 2030. In the view of National Diabetes Statistics report 2017, 30.3 million people have diabetes in the United States (9.4%) of total population, out of which, 23.1 million are diagnosed and 7.2 million (23.8%) people with Diabetes are undiagnosed. One of the recently i Read More

Introduction: (COPD) Chronic Obstructive Pulmonary Disease is a partially reversible and treatable lung disease, characterized by progressive limitation of airflow. It is one of the main causes of mortality and morbidity worldwide. Methods: An easy, precise and selective reversed-phase liquid chromatographic method, with stabilityindicating assay was established and validated for the determination of indacaterol maleat Read More

Background: Metoclopramide is a potent dopaminergic antagonist utilized for treating gastrointestinal disorders. The aim of this study was to examine the pharmacokinetics of oral formulation of metoclopramide in the Pakistani volunteers. Methods: This open label, single dose, pharmacokinetic study was executed in non-smoking, 12 Pakistani healthy males, treated with a single 20 mg oral tablet dose of metocl Read More

Objective: The aim of the present work is to achieve a novel highly sensitive chromatographic method for the simultaneous determination of hepatitis C agents, sofosbuvir and velpatasvir from human plasma using ritonavir as an internal standard. Methods: Chromatographic separation was achieved using Hypersil C18 column (50mm x 4.6mm, 3μm) with an isocratic elution mode using the mobile phase composition 10 Read More

Background: Gliclazide Impurity A (GI-A) is one of the gliclazide impurities, as described in the European Pharmacopoeia. Objective: The objective of this study was to develop and validate simple, robust and accurate Reverse- Phase High-Performance Liquid Chromatography (RP-HPLC) method for estimation of gliclazide along with GI-A in bulk by optimising chromatographic parameters using Box Behnken design in response surf Read More

Background: Four major degradation products (1-4) of pralatrexate injection were formed under hydrolytic and light stress conditions. The impurities 1 and 2 were the potential photo degradation products and the impurities 3 and 4 were the potential hydrolytic degradation products. Objective: To prepare and characterize the novel degradation impurities 1, 2, 3 and 4 of pralatrexate injection using NMR, HR MS and IR Read More

Background: Econazole nitrate and triamcinolone acetonide are one of the topical antifungal corticosteroid fixed combinations. Although this combination has been literately investigated, yet their ternary mixture with benzoic acid as preservative lack of a simple method for its determination. Objective: The objective of this work is to present simple, accurate, precise and low cost reversed-phase liquid chromato Read More

Background: Retinol and vitamin E are fat-soluble vitamins crucial for human health, yet their isomers’ distributions in the human body are still known roughly. In order to figure out the physical condition and evaluate the nutritional status of an individual, it is imperative to analyze retinol and VE isomers in human serum. Objective: This work aims to establish a rapid and simple high-performance liquid chromatography with flu Read More

Introduction: A suitable LC-MS method for the quantitative determination of genotoxic impurities such as alkyl p-toluene sulfonates in Cabazitaxel was developed. Alkyl p-toluene sulfonates were estimated by LC-MS method using Waters Symmetry C18 (75x4.6 mm), 3.5 μ column. Materials and Methods: Column temperature was maintained 40 °C. Injection volume was 10 μL and flow rate was set as 0.8 mL/min. Sampler temper Read More

Background: Cefoperazone Sulbactam injection is a cephalosporin antibiotic with a β- lactamase inhibitor used in the treatment for intra abdominal infections, Urinary track infections, surgical infections, etc. The combination is not official in any of the pharmacopeia for their content and impurities determination. Introduction: The present study involves the development of a simple, rapid, accurate, sensitive and stability in Read More

Background: As first-line treatments for diabetes, sitagliptin and metformin have been widely prescribed as a combination to enhance the therapeutic effect. Objective: To establish a methodology to simultaneously monitor the two drugs in vivo by a reversedphase Liquid Chromatography-Tandem Mass Spectrometric (LC-MS/MS) method. Methods: The two drugs were extracted from 50 μl human plasma b Read More

Background: Meloxicam is as a non-steroidal anti-inflammatory drug that indicates a strong anti-inflammatory, analgesic and antipyretic activity. It is used in the treatment of osteoarthritis arthritis, osteoarthritis and rheumatoid arthritis in the form of various pharmaceutical preparations. Objective: The aim of the work was an elaboration of chromatographic conditions enabling the complete separation of impurities A and Read More

Background: CoQ10 is a very important compound which is found in every tissue of our organism. It participates in the processes of cellular respiration and ATP production. Also, it acts as a strong antioxidant. In an organism, it is represented in two forms: oxidized (ubiquinone) and reduced (ubiquinol). Its low blood level may be a signal for a list of diseases. Materials and Methods: This study developed and compared Read More

Background: Hedyotis diffusa is one of the most extensively used Chinese herbs for the treatment of varieties of cancers in the folk of China. The ingredients of the preparation are still not very clear and the quality control method of the herb medicine requires further improvement. Introduction: In this paper, the quantitative methods for the quality control of H. diffusa were originally developed by using UPLC-UV. Met Read More