Current Pharmaceutical Analysis - Volume 19, Issue 2, 2023

Background: Analytical techniques play a vital role in developing patient-friendly dosage forms in the pharmaceutical industry. Presently, numerous sophisticated and highly delicate modern analytical instruments are available in pharmaceutical industries to assess active pharmaceutical ingredients or other excipients present in different pharmaceutical matrices and biological fluids. Assortment of the most suitable analytical techniques for analysing any component during the drug development process is challenging as it affects the final product's quality, safety, and efficacy. Introduction: Tadalafil (TDL) is the most flexible second-generation Phosphodiesterase-5 inhibitor. It treats erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension as first-line therapy, either alone or with other medications. This review paper aims to highlight the varieties of new analytical techniques (like UV-Visible spectroscopic technique, HPLC, HPTLC, Electroanalytical technique, Spectrofluorimetry, GC-MS, LC-MS) that have been reported for quantification of TDL as a single or in the combined form present in bulk material as well as in different biological or pharmaceutical matrices, their pros and cons, and future potential of such methods. Conclusion: This article's reported methods are accurate, sensitive, and cost-effective. Applying AQbD and green analytical chemistry with greener organic solvents and reagents in some of the reported methods opens a new era of analytical method development that will aid in future growth for the estimation of TDL.

According to the WHO’s data for 2018, the global cancer burden was estimated to have risen to 18.1 million new cases and which alone accounted for 9.6 million deaths. Cancer is a group of diseases known as tumors that often spreads throughout the body, and may cause harm to multiple organs in the body. The global pharmaceutical spending is around 19% of the R&D cost annually to discover new and potent therapeutic agents. The major problems associated with currently available anticancer drugs are drug resistance and their side effects. They are the most widely explored groups of drugs either using instrumental or bioanalytical methods. In this review, we have compiled and reviewed the analytical and bio-analytical methods of some anticancer drugs developed by different authors. The review also briefly discusses the broad categories of cytotoxic drugs and targeted-based anticancer drugs. The analytical and bioanalytical methods of cytotoxic drugs such as alkylating agents, antimetabolites, hormones, and targetedbased drugs reported earlier and in recent research, articles are discussed in detail. These analytical methods are prerequisites for both the pharmaceutical industry and academics for their impurities profiling and qualitative as well as quantitative estimation. The accuracy, precision, LOD, and LOQ studies by UV-HPLC, LC-MS, and fluorometry HPLC are discussed. Some of the advanced methods developed, in the case of ifosfamide using Au/Pd@rGO@p(L-Cys) and the production of vincristine by endophytic fungi, are also included. This will further embolden the efforts of different researchers working in this field and ease the challenges they face through the analytical development of these drugs.

Background: Fixed-dose combinations (FDCs) are renowned formulations that contain two or more drugs pooled in a single dosage form. Their recognition is justified due to several advantages, such as impending therapeutic efficacy, reducing the episodes of adverse drug effects, having pharmacokinetic advantages, reducing pill burden, reducing the dose of individual drugs, and decreasing drug resistance development. Objective: Recently, an FDC tablet of remogliflozin etabonate (100 mg), vildagliptin (50 mg), and metformin HCl (500/1000 mg) has been approved for the treatment of type 2 diabetes mellitus. No analytical method has been reported thus far for this newly approved combination. Methods: Thus, this review collected and simplified information on reported analytical techniques and physicochemical and biological properties for the above-cited FDCs. The authors have explored various authenticated scientific journals, and simplified information was presented to meet the objectives. Results: The reported methods are spectroscopy (40%, 20% & 33%), HPTLC (10%, 14% & 20%), HPLC (50%, 49% & 41%), hyphenated techniques (Nil, 14% & 5%) and electrophoresis methods (Nil, 2% & 1%) for remogliflozin etabonate, vildagliptin and metformin HCl, respectively. Conclusion: Such extensive data would be useful to analysts in developing an analytical method for the analysis of the recently approved FDCs.

Background: This study aimed to develop a sensitive, rapid method based on HPLC-MS/MS for the quantification of Montelukast in human plasma utilizing Montelukast-D6 as an internal standard. Montelukast is a leukotriene inhibitor and is used to prevent asthma attacks in adults and children. Method: Separation was achieved using Thermo Hypersil GOLD™ Cyano HPLC columns (50 × 4.6 mm; 5 μm) with a mobile phase consisting of 0.5 mM ammonium chloride: ACN (20:80%; v/v). Results: The method was found to be linear over a concentration range of 10.0 - 600.0 ng/mL with a correlation coefficient (r2) ≥ 0. 0.9989. The stabilities of Montelukast and internal standard were assessed in several conditions with recovery results > 85%. The precision results were less than 4.0%, while the accuracy results were within 93.0 107.0%. The method proved to be selective with no matrix effect. Conclusion: This method was found to be highly reproducible and was utilized successfully for the analysis of plasma samples following the oral administration of Montelukast (10 mg) in 28 healthy male human volunteers.