DEVELOPMENT OF CLEANING METHOD VALIDATION TECHNIQUES FOR PIROXICAM AND TELMISARTAN

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (08) ◽  
pp. 49-53
Author(s):  
Padmavathi P Prabhu ◽  
Paramita Das ◽  
Aditya Tari ◽  

To determine effectiveness of cleaning, analytical methods were validated for piroxicam and telmisartan. The drugs were selected on the basis of solubility in water. Water is the major solvent used for cleaning of equipments. These drugs are practically insoluble in water, so they may leave product residue even after cleaning of the equipments and necessitate lot of water for cleaning. So, any analytical method used to determine the cleanliness should be effective. During analytical method validations, following parameters were evaluated i.e. linearity, specificity, LOQ, LOD, and recovery studies by swab sampling and rinse sampling techniques. The visual cleanliness criteria was also evaluated by spiking known amount of samples on SS plates. From the results it was concluded that the developed analytical method was sensitive and accurate. For piroxicam: UV spectrophotometric analytical method was developed which showed an absorption maxima λmax at 356 nm wavelength and linearity range 0 to 25 µg/mL. Recovery of drug from swab sampling and rinse sampling techniques were found satisfactory and within the acceptance criteria. For telmisartan, UV spectrophotometric analytical method was developed which showed an absorption maxima λmax at 226 nm wavelength and linearity range 0 to 10 µg/mL. Recovery of drug from swab sampling and rinse sampling techniques were found satisfactory and within the acceptance criteria

Bioanalysis ◽  
2021 ◽  
Author(s):  
Yoshiaki Ohtsu ◽  
Seiji Tanaka ◽  
Harue Igarashi ◽  
Masaaki Kakehi ◽  
Tamiki Mori ◽  
...  

Biomarkers are an important drug developmental tool. Assessment of quantitative analytical methods of biomarkers is not included in any regulatory documents in Japan. Use of biomarkers in clinical evaluations and supporting the post-marketing evaluation of drug efficacy and/or adverse reactions requires assessment and full validation of analytical methods for these biomarkers. The Biomarker Analytical Method Validation Study Group is a research group in Japan comprising industry and regulatory experts. Group members discussed and prepared this ‘points to consider document’ covering measurements of endogenous metabolites/peptides/proteins by ligand binding assays and chromatographic methods with or without mass spectrometry. We hope this document contributes to the global harmonization of biomarker assay validation.


2019 ◽  
Vol 2 (2) ◽  
Author(s):  
Sai Raghuveer Chava

This paper describes the current method transfer and method validation process following FDA guidance and ICH guidelines in a cGMP environment. The analytical method validation and transfer have been playing a key role in Phase 1 to Phase 3 projects. This paper discusses the method validation and method transfer based on the phase of relevance in the GMP environment. It also describes the number of validation or qualification steps required for the method transfer. When the analytical methods are utilized to generate results about the characteristics of drug-related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to administering the drug to patients. Analytical method validation required during drug development and manufacturing and these analytical methods is fit for their intended purpose. To comply with the requirements of GMP pharmaceutical industries should have an overall validation policy that documents how validation will be performed. The purpose of this validation is to show that processes involved in the development and manufacture of the drug, production, and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.


2012 ◽  
Vol 5 (1) ◽  
pp. 3-30 ◽  
Author(s):  
G. Shephard ◽  
F. Berthiller ◽  
P. Burdaspal ◽  
C. Crews ◽  
M. Jonker ◽  
...  

This review highlights developments in mycotoxin analysis and sampling over a period between mid-2010 and mid-2011. It covers the major mycotoxins: aflatoxins, Alternaria toxins, ergot alkaloids, fumonisins, ochratoxin, patulin, trichothecenes, and zearalenone. Analytical methods for mycotoxins continue to be developed and published. Despite much interest in immunochemical methods and in the rapid development of LC-MS methodology, more conventional methods, sometimes linked to novel clean-up protocols, have also been the subject of research publications over the above period. Occurrence of mycotoxins falls outside the main focus of this review; however, where relevant to analytical method development, this has been mentioned.


Author(s):  
Punna Venkateshwarlu ◽  
Mehul M. Patel

This article reviews the various analytical methods reported so far in the literature for the determination of stability and impurity profile the lenalidomide and palbociclib anti cancer drugs in single or combination with other drugs in bulk, pharmaceutical dosage forms, biological fluids, stability indicating and impurity profiling methods. The analytical methods used for the estimation of lenalidomide and palbociclib anticancer drugs reviewed in this paper includes ultraviolet spectrophotometry,high performance liquid chromatography (HPLC) ,ultra performance liquid chromatography (UPLC) ,liquid chromatography-mass spectrometry (LC-MS) and electrophoresis. This review focus on the effect of all chromatographic parameters so as to provide as fast, reliable and cost effective methodology of testing. Method development is the process of proving that analytical method is acceptable for use to measure the concentration of active pharmaceutical ingredient in a specific compound dosage form which must be validated to provide reliable data for regulatory submissions. This reviewed is mainly on analytical method development and validation, stability indicating methods, simultaneous estimation methods and bioanalytical methods. The review covers the time period from 2007 to 2019 during which analytical methods including all types of spectrophotometric and chromatographic techniques were reported. The Review covers lenalidomide and palbociclib API and formulation analytical and bioanalytical methods.


2009 ◽  
Vol 2 (2) ◽  
pp. 34 ◽  
Author(s):  
Marco Aurélio Carino Bouzada

The objective of this paper is to establish a dichotomy - opposing analytical methods (such as Queue Theory) to experimental methods (such as Simulation) and discussing their adequateness to complex operations - set up in the matter of dimensioning the handling capacity of a large brazilian call centers company. The literature related to the application of such methods at call centers is reviewed, and the way the question is treated nowadays by the company is described. Then an experimental approach is suggested to be implemented as an alternative methodology to deal with the issue, instead of the analytical method in use. The results obtained are used to justify the adequacy of the experimental approach to the modern call centers operation, as long as it is possible to have the model closer to reality. The main implication points to a better understanding of the operation achieved with the new approach


Author(s):  
Tri Yudha Ardiyanto ◽  
Tajuddin Pogo

This research examines and analyzes motivation, work discipline and organizational culture on the performance of employees at PT Sharp Electronics Indonesia (division Customer Satisfaction) that have not been maximized, due to the achievement of the results of performance appraisal in the 2017L and 2018F periods there was a decrease in each assessment indicator which greatly impacted employee performance. The method used is quantitative research. With a population of 110 employees, PT Sharp Electronics Indonesia (Division Customer Satisfaction), with sampling techniques using Slovin formula with a total of 86 employees. The analytical method used in this study is multiple linear regression. The results of the study show that Motivation, Work Discipline and Organizational Culture together (Simultaneous) significantly influence the Performance of Employees of PT Sharp Electronics Indonesia (Division Customer Satisfaction).


Sign in / Sign up

Export Citation Format

Share Document