Low level drug product API form analysis – Avalide tablet NIR quantitative method development and robustness challenges

2014 ◽  
Vol 89 ◽  
pp. 268-275 ◽  
Author(s):  
Duohai Pan ◽  
George Crull ◽  
Shawn Yin ◽  
John Grosso
Keyword(s):  
Quantitative Method ◽  
Method Development ◽  
Drug Product ◽  
Form Analysis ◽  
Low Level

Quantitative method development for measurement of Maesa lanceolata saponins by LC-MS

Planta Medica ◽  
2006 ◽  
Vol 72 (11) ◽  
Author(s):  
L Pieters ◽  
M Theunis ◽  
S Apers ◽  
A Vlietinck
Keyword(s):  
Quantitative Method ◽  
Method Development

scholarly journals RP-HPLC Method Development and Validation for Cleaning Residue Determination of Tofacitinib Citrate in Tofacitinib Tablets

2021 ◽  
pp. 262-276
Author(s):  
Thaticherla Kaleswararao ◽  
Duvvuri Suryakala
Keyword(s):  
Method Development ◽  
Drug Product ◽  
Hplc Method ◽  
Solution Stability ◽  
Sample Analysis ◽  
Validation Data ◽  
Manufacturing Equipment ◽  
Rp Hplc ◽  
Hplc Method Development ◽  
Development And Validation

A novel, Specific, and precise RP-HPLC method was developed to determine the residue content of Tofacitinib citrate left on the surface of equipment used in the manufacturing process. The manufacturing equipment considered in assessment of cleaning has been verified and found the tools assembled to the equipment are made up of Stainless steel, Glass, Teflon and plastic. Hence, these surfaces of manufacturing equipment that come in contact with the drug product during manufacturing are considered for evaluation of the cleaning procedure. By developing and validating an analytical method for residue estimation, the manufacturing equipment can be evaluated for efficient cleaning and to release the manufacturing equipment for further intended use by minimizing the cross contaminations. The stationary phase suited for the well separation of components is CAPCELL PAK C18 150 x 4.6 mm, 3 μm; 0.4 % perchloric acid and acetonitrile in the ratio of 85:15 % v/v is the mobile phase pumped at a flow rate of 1.2 mL/min through the column at temperature of 40 ºC. Each run extended for 10 min as the Tofacitinib peak elutes at RT of 5.2 min. The method has been validated successfully for Specificity, Precision, Linearity, Accuracy, Ruggedness and Filter validation of both rinse and swab methods. The LOD, LOQ concentrations found to be 0.006, 0.019 µg/mL for swab method and 0.03 and 0.1 µg/mL for rinse method respectively. The correlation coefficient is 0.999 and method found linear from LOQ to 500% for swab method and LOQ to 200% for rinse method. Solution stability has been established to ensure the test solution get tested within the stable time (4 Days). Based on the filter validation data, it is concluded that PVDF filter is not suitable for cleaning sample analysis and 2 mL sample should be discarded when 0.45 µm Nylon filter is used for cleaning sample analysis.

Modification of the Rapid Screening Method for Aflatoxin in Corn for Quantitative Use

1985 ◽  
Vol 68 (3) ◽  
pp. 453-456
Author(s):  
Joseph R Spilmann
Keyword(s):  
Quantitative Method ◽  
Screening Method ◽  
Rapid Screening ◽  
Low Level ◽  
Modified Method ◽  
Corn Products ◽  
Aoac Method ◽  
Rapid Screening Method ◽  
High Level

Abstract A study was made to determine if the official AOAC method for screening of aflatoxin in corn could be modified for use as a quantitative method. Several different corn products were analyzed using the modified method, with an average savings of over 1 h/sample vs the CB method. Average recoveries for aflatoxin Bt were 94% for the low level spiked samples and 108% for the high level. Samples of corn and corn products containing naturally incurred aflatoxin were also analyzed with the modified method, and the results compared favorably with those obtained by the CB method.

scholarly journals HUBUNGAN MASA KERJA DENGAN STRES KERJA PADA PU STAKAWAN PERPUS TAKAAN UNIVERSITAS GAD JAH MADA YOGYAKARTA

2015 ◽  
Vol 3 (1) ◽  
Author(s):  
Sarwono Sarwono ◽  
Purwono Purwono
Keyword(s):  
High School ◽  
Work Stress ◽  
Stress Level ◽  
Quantitative Method ◽  
Total Population ◽  
Senior High School ◽  
Primary Data ◽  
Graduate Level ◽  
Population Research ◽  
Low Level

A stress could happen to everyone. A stress which is related to work is well known as a wark stress. The more someone works the more stressors (sources of stress) will be received. Its research is aimed at recognizing the correlation between work length and work stress on Librarian of Library of Gadjah Mada University. The research uses a quantitative method with a questianer as a data collecting instrument. It is also a population research that takes total population of 3l persons. Primary data is processed tofind out the work stress level. The outcome of the research that has been already known is about 41,9 o%r espondentso r l3 librarians got low level work stressa nd 58,1% o respondentso r lS librarians don'tg ot stressI.t consistso f 7 mena nd 6 womano fwhich 2 of thema re from senior high school; 6 librarians arefrom diploma; 4 librarians arefrom undergraduate, and the last one isfrom graduate level. Viewingfrom respondentsa ges,l ibrarians that are affectedb y low level workstress are 5 librarians (31-40years old); 3librarians (41-50years old) and 5librarians (above 50years old). Viewingfrom the work lengtHS of the libarrians that experience low level work stress are divided into 4 groups. For librarians who have work length less than 6 years have got no work stress; 6-12 years is I rspondent; 13-18 years is 4 respondents; and more than 18 years is 7 respondents;havegotlowlevelofworkstress.Thceo nclusion is that a work stressc ould happen to librarians of Library of Gadjah Mada University. Meanwhile, the result of statistic test using spearman'sr ho testi s knownt hatp significancel evel is 0,06w hich meanst hat it is bigger thanp table that only 0,05.I t meanst hat hypotheticz ero is acceptedI.t could be said that therei s no significance correlation betweenwork length andwork stress on librarian of Library of Gadjah Mada UniversiQ. Keywords : work length, work stress, librarian

scholarly journals Ultra performance liquid chromatographic method for simultaneous quantitation of degradation products of telmisartan and hydrochlorothiazide in combination dosage form

2020 ◽  
Vol 11 (2) ◽  
pp. 2070-2082
Author(s):  
Narasimha Reddy G P ◽  
Sreenivasulu Reddy T ◽  
Sidda Reddy K ◽  
Shashi Kumar K N
Keyword(s):  
Mobile Phase ◽  
Method Development ◽  
Limit Of Detection ◽  
Degradation Products ◽  
Drug Product ◽  
Wave Length ◽  
Stability Study ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating

This work is intended to thrive a stability indicating Ultra performance liquid method for the estimation of (TLM) and (HCTZ) and degradation products pharmaceutical dosage forms. Separation was carried out on Zorbax Eclipse XDB C-18(50 x 2.1 mm, 1.7 ) column using a gradient method. Mobile phase A is 10mM KH2PO4 having 1% (v/v) of and mobile phase B is used in this work. 0.5 / minute is the flow of rate and at 271nm noticed wave length is monitored. Method development trails were carried out on six different columns. For specificity, limit of quantification, limit of detection, linearity, accuracy, method precision, robustness and stability this method is validated. Correlation coefficient of the impurities is more than 0.99. Stability indicating method confirmed that there were no interference of all impurities of TLM and HCTZ. Hence, developed LC method was stability indicating and well applied for drug product stability study as well as to quality monitoring.

scholarly journals Quantitative Method Development and Validation of Naloxone and 6α‐naloxol from Male African Green Monkey Plasma.

2018 ◽  
Vol 32 (S1) ◽  
Author(s):  
Veera Venkata Ratnam Bandaru ◽  
Justin N Vignola ◽  
Samantha R Litvin ◽  
Amber M Packer ◽  
Amy S Rizkallah ◽  
...  
Keyword(s):  
Quantitative Method ◽  
Method Development ◽  
African Green Monkey ◽  
Green Monkey ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Monkey Plasma

scholarly journals Direct Stereoselective Method Development and Validation of Elagolix on Zwitterionic Chiral Stationary Phase by High-Pressure Liquid Chromatography

2020 ◽  
pp. 517-524
Author(s):  
Thirupathi Choppari ◽  
Srinivasu Gunnam ◽  
Lakshmi Narayana Chennuru ◽  
Parameswara Murthy Cherla
Keyword(s):  
Stationary Phase ◽  
Chiral Stationary Phase ◽  
Method Development ◽  
Drug Product ◽  
Research Work ◽  
Cinchona Alkaloid ◽  
Chromatographic Technique ◽  
Ich Guidelines ◽  
Development And Validation ◽  
High Degree

A specific, sensitive and accurate chiral technique has been developed for the quantification of elagolix enantiomer in a drug product. The present research work represents the development and validation of chromatographic technique for the separation of elagolix enantiomers on a chiral stationary phase (CSP) comprising a zwitterionic selector derived from cinchona alkaloid and sulfonic acid CHIRALPAK ZWIX (+)  under isocratic condition containing 50mM Acetic acid and 25mM diethyl amine in water and methanol in the ratio of 02:98 v/v with 0.5 ml min-1 flow rate. Temperature of the column was monitored at 40°C with a resolving factor more than 3.2. The eluted compounds were monitored at 275 nm. The optimized method has high degree of selectivity with lower limiting values of detection and quantitation and were found to be 2.0 ng/ml and 7.5 ng/ml, respectively for the enantiomeric chiral impurity. The developed method was subjected for validation as per the ICH guidelines, produced good findings regarding specificity, accuracy, precision, robustness and linearity.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND VELPATASVIR DRUG PRODUCT BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD

2018 ◽  
Vol 11 (2) ◽  
pp. 164 ◽  
Author(s):  
Kalpana Nekkala ◽  
Shanmukha Kumar J V ◽  
Shanmukha Kumar J V ◽  
Shanmukha Kumar J V ◽  
Ramachandran D ◽  
...  
Keyword(s):  
Liquid Chromatography ◽  
Analytical Method ◽  
Method Development ◽  
Drug Product ◽  
Ultra Violet ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Analytical Method Validation ◽  
Validation Parameters

 Objectives: The purpose of the research is to develop a simple, precise, economical, accurate, reproducible, and sensitive method for the estimation of sofosbuvir and velpatasvir drug product by rp-hplc methodMethods: New Analytical method was developed for the estimation of Velpatasvir and Sofosbuvir in drug product by liquid chromatography. The chromatographic separation was achieved on C18 column (Luna 18 150*4.6mm3.0um) at ambient temperature. The separation achieved employing a mobile phase consists of 0.1%v/v Formic acid in water: Methanol: Acetonitrile (35:40:25). The flow rate was 0.8ml/ minute and ultra violet detector at 269nm. The average retention time for Velpatasvir and Sofosbuvir found to be 2.62 min and 3.72 min.Results: The developed method was validated as per the ICH analytical method validation guidelines. All validation parameters were within the acceptable range. The assay methods were found to be linear from 80-240 µg/ml for Sofosbuvir and 20-60µg/ml for Velpatasvir. The correlation coefficient was 0.9998 and 0.9992 for velpatasvir and sofosbuvir respectively.  The mean percentage recovery for the developed method was found to be in the range of 98.4-100.4% for velpatasvir and 98.6-100.6% for sofosbuvir. The developed method was also found to be robustConclusion: The developed method was found to be suitable for the routine quantitative analysis of Velpatasvir and Sofosbuvir in bulk and pharmaceutical dosage form. It was also concluded that developed method was accurate, precise, linear, reproducible, robust, and sensitive. 

scholarly journals Selected Aspects of Iran’s Hydrological Security

2019 ◽  
pp. 335-350
Author(s):  
Anna Sakson-Boulet
Keyword(s):  
Decision Making ◽  
Water Resources ◽  
Fresh Water ◽  
Quantitative Method ◽  
Water Security ◽  
The State ◽  
Ecological Crisis ◽  
Legal Analysis ◽  
Low Level ◽  
Research Questions

The main objective of this paper is to analyze Iran’s hydrological security and to verify the hypothesis that the low level of Iran’s hydrological security is one of the country’s most important ecological threats. An attempt to answer the following research questions is made using the quantitative method, decision-making method and institutional and legal analysis: (1) what water resources does Iran have, and are citizens suffering from a shortage of water?; (2) is the management of groundwater, closed reservoirs and rivers sustainable?; (3) do the actions of the Iranian authorities safeguard the hydrological security of the state? The analysis of the factors of Iran’s water security carried out in this paper leads to the conclusion that this country is facing a serious ecological crisis resulting from shrinking fresh water resources.

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