Method Development of an Analytical Procedure for the Determination of Clofarabine in Pharmaceutical Formulations

A novel, simple and economic high performance liquid chromatography (HPLC) method has been developed for the estimation of Clofarabine in bulk and tablet dosage form with greater precision and accuracy.The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed HPLC method is simple, specific, rapid, reliable and reproducible. Hence the proposed method can be applied for the routine quality control analysis of Clofarabine in bulk and tablet dosage forms. All the components of the system are controlled using SCL-10Avp System Controller. Data acquisition was done using LC Solutions software.

HTSQualC is a flexible and one-step quality control software for high-throughput sequencing data analysis

Use of high-throughput sequencing (HTS) has become indispensable in life science research. Raw HTS data contains several sequencing artifacts, and as a first step it is imperative to remove the artifacts for reliable downstream bioinformatics analysis. Although there are multiple stand-alone tools available that can perform the various quality control steps separately, availability of an integrated tool that can allow one-step, automated quality control analysis of HTS datasets will significantly enhance handling large number of samples parallelly. Here, we developed HTSQualC, a stand-alone, flexible, and easy-to-use software for one-step quality control analysis of raw HTS data. HTSQualC can evaluate HTS data quality and perform filtering and trimming analysis in a single run. We evaluated the performance of HTSQualC for conducting batch analysis of HTS datasets with 322 samples with an average ~ 1 M (paired end) sequence reads per sample. HTSQualC accomplished the QC analysis in ~ 3 h in distributed mode and ~ 31 h in shared mode, thus underscoring its utility and robust performance. In addition to command-line execution, we integrated HTSQualC into the free, open-source, CyVerse cyberinfrastructure resource as a GUI interface, for wider access to experimental biologists who have limited computational resources and/or programming abilities.

Product Quality Control Analysis with Statistical Process Control (SPC) Method in Weaving Section (Case Study PT.I)

- PT.I is a company that produces synthetic rattan furniture on an export scale. The various products at PT.I are an attraction for consumers, such as classic and modern weaving models. However, the number of defects produced is higher than the tolerance limit company. Based on data from the weaving section, it shows that there are 5 types of defects that are not in accordance with the standards and quality that have been determined by the company. The purpose of this study is to identify the types of defects that often occur in PT. I and identify the main factors causing product defects using the SPC method. The seven tools consist of a check sheet, histogram, stratification, scatter diagram, p control chart, Pareto diagram, and fishbone diagram. The results showed that the number of defects in October and November exceeded the limit set by the company. The highest level of disability occurred in October. The higher the number of production, the higher the number of product defects. Based on the results of the p control chart, it can be seen that the product is outside the control limits that it should have. The process is in a state of uncontrollability or is still experiencing deviations. To suppress or reduce the number of product defects that occur in production, 3 types of dominant defects can be applied, namely the woven model (254 units), loose woven (122 units), and nail-looking woven (119 units). Factors causing defects in production are derived from human factors/workers, methods, materials/raw materials and work environment.

Development of novel HPTLC method for determination of imidazole antifungal drug fenticonazole: Exploring hydrotropy

A novel High-Performance Thin-Layer Chromatography (HPTLC) method was portrayed for the determination of Fenticonazole Nitrate (FTZ) in Bulk and Vaginal Capsules. The estimation of Fenticonazole Nitrate was achieved on aluminium pre-coated sheets of silica gel 60 F(10 cm × 10 cm) using mobile phase Toluene: Methanol: Triethylamine (4:1:0.5 v/v/v). Densitometry detection of Fenticonazole Nitrate was performed at 254nm. Fenticonazole nitrate demonstrated a strong correlation with a coefficient of correlation of 0.999 over the concentration range of 500 – 3000 ng/band. The Rvalue for Fenticonazole Nitrate was found to be 0.65. As per International Conference on Harmonization the established method was successfully validated to various parameters like accuracy, precision, sensitivity, specificity, robustness and shows the satisfactory results for all parameters. The recognized method is simple, accurate, precise, robust, sensitive and economical in nature. This method can be used for quality control analysis of Fenticonazole Nitrate in bulk and vaginal capsules.

Chemistry, Pharmacokinetics, Pharmacodynamics and Analytical methods of Bilastine, a histamine H1 receptor antagonist: An update

: Bilastine (BIL) is the new generation antihistamine that is used to relieve the symptoms of hayfever, chronic urticaria and other forms of allergic rhinitis. Chemically it is known 2-[4-[2-[4-[1-(2-ethoxyethyl) benzimidazole-2-yl] piperidine-1-yl] ethyl] phenyl]-2-methylpropane acid. The chemical structure of BIL having hydrophilic carboxylic substituent. BIL has a longer duration of action due to potent binding affinity to the H1 receptor. This review summarizes the properties, characteristics, chemistry along with analytical and bioanalytical methods used for estimation of BIL from different scientific articles. The literature has demonstrated some methods for quantification of BIL in various sample matrix and pharmaceutical products. Frequently and extensively used antihistaminics are in the clinic practice, a novel, effective, economical and safe analytical methodology is required for routine quality control analysis, bioavailability and bioequivalence studies. Furthermore, this narrative review summarizes available data on chemistry, pharmacology and analysis of BIL in different matrix.