Development and Validation of an Analytical Method Readily Applicable for Quality Control of Tabebuia impetiginosa (Taheebo) Ethanolic Extract

2018 ◽  
Vol 101 (3) ◽  
pp. 695-700 ◽  
Author(s):  
Yan Jin ◽  
Kyung Min Jeong ◽  
Jeongmi Lee ◽  
Jing Zhao ◽  
Su-Young Choi ◽  
...  
Keyword(s):  
Quality Control ◽  
Analytical Method ◽  
Ethanolic Extract ◽  
Development And Validation

“BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF PROPOFOL IN K3EDTA HUMAN PLASMA BY USING LC-ESI-MS/MS”

2019 ◽  
Vol 8 (5) ◽  
Author(s):  
Ashok Kumar ◽  
Dr. D.B. Joshi ◽  
Dr. R.S. Bhadauria
Keyword(s):  
Quality Control ◽  
Analytical Method ◽  
Method Development ◽  
Solid Phase ◽  
Extraction Methods ◽  
Bioanalytical Method ◽  
Biological Matrix ◽  
Liquid Liquid Extraction ◽  
Method Development And Validation ◽  
Development And Validation

Bioanalytical method development is the process of creating a procedure to enable a compound of interest to be identified and quantified in a biological matrix. A compound can often be measured by several methods and the choice of analytical method involves many considerations. Analysis of drugs and their metabolites in a biological matrix is carried out using different extraction techniques like liquid-liquid extraction, solid phase extraction (SPE) and protein precipitation from these extraction methods samples are spiked with calibration (reference) standards and using quality control (QC) samples. These methods and choice of analytical method describes the process of method development and includes sampling, sample preparation, separation, detection and evaluation of the results. The developed process is then validated. These Bioanalytical validations play a significant role in evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and toxicokinetic studies. In which different parameters like accuracy, precision, selectivity, sensitivity, reproducibility, and stability are performed. Keywords: - LLE, SPE, Quality control samples, Bioequivalence, Bioavailability, Validation.

scholarly journals Development and Validation of Analytical Method for Determination of an Important Flavonoid in Malva neglecta

2019 ◽  
pp. 1-8
Author(s):  
Naira Nayeem Akmal ◽  
Mohd. Imran ◽  
Mohammad Ali Mujtaba
Keyword(s):  
Quality Control ◽  
Calibration Curve ◽  
Analytical Method ◽  
Methanolic Extract ◽  
Hplc Method ◽  
Average Recovery ◽  
Acceptance Criterion ◽  
Development And Validation ◽  
Validation Of Analytical Method

Development of genuine and dependable analytical methods which profile marker phytoconstituents in   an extract containing a mixture of several components is a challenging task. A simple, rapid, precise, and reliable HPLC method was developed for quantification of quercetin from the methanolic extract of Malva neglecta. The estimation was carried out using Phenomenex Gemini-NX-5 µm C18 .The parameters  considered for validation were accuracy, precision, linearity and robustness. The calibration curve was found to be linear in a concentration range of 20–100 μg/mL.The correlation coefficient was r2=0.9996. The % average recovery of quercetin was found to be in the range of 99.82 to 100.52% which was within the acceptance criterion indicating the accuracy of the method. The results of the robustness study indicated that there is no influence of minor changes. The developed and validated method can be successfully used for the determination of quercetin in Malva neglecta; thereby helping in authentication and quality control of this plant.

scholarly journals The development and validation of a sensitive HPLC-MS/MS method for the quantitative and pharmacokinetic study of the seven components of Buddleja lindleyana Fort.

RSC Advances ◽  
2021 ◽  
Vol 11 (42) ◽  
pp. 26016-26028
Author(s):  
Xia Zhang ◽  
Zhi-qing Zhang ◽  
Li-cang Zhang ◽  
Ke-xin Wang ◽  
Lan-tong Zhang ◽  
...  
Keyword(s):  
Quality Control ◽  
Pharmacokinetic Study ◽  
Development And Validation

Quality control and pharmacokinetics of Buddleja lindleyana Fort by HPLC-MS/MS.

scholarly journals Anti-diabetes Constituents in Leaves of Smallanthus sonchifolius

2010 ◽  
Vol 5 (1) ◽  
pp. 1934578X1000500 ◽  
Author(s):  
Xiang Zheng ◽  
He Fan ◽  
Kang Ting-Guo ◽  
Dou De-Qiang ◽  
Gai Kuo ◽  
...  
Keyword(s):  
Quality Control ◽  
Chlorogenic Acid ◽  
Caffeic Acid ◽  
Analytical Method ◽  
Inhibitory Effect ◽  
Hplc Method ◽  
Smallanthus Sonchifolius ◽  
Rp Hplc

The inhibitory effect of smallanthaditerpenic acids A, B, C and D previously isolated from leaves of Smallanthus sonchifolius (yacon) on α-glucosidase were examined and their IC50 were determined to be 0.48 mg/mL, 0.59 mg/mL, 1.00 mg/mL, and 1.17 mg/mL respectively. In addition, a rapid, reliable RP-HPLC method for the analysis of chlorogenic acid, caffeic acid, and smallanthaditerpenic acids A and C in yacon leaves was established, and the variation in their contents in leaves from plants cultivated in different places and collected at different times of the year were compared. The established analytical method for determining smallanthaditerpenic acids A and C, chlorogenic acid and caffeic acid presented good results and could be used as a method for the quality control of S. sonchifolius leaves.

Development and Validation of an HPLC Method for Determination of Spirotetramat and Spirotetramat cis enol in Various Vegetables and Soil

2013 ◽  
Vol 96 (3) ◽  
pp. 670-675 ◽  
Author(s):  
Balwinder Singh ◽  
Kousik Mandal ◽  
Sanjay K Sahoo ◽  
Urvashi Bhardwaj ◽  
Raminderjit Singh Battu
Keyword(s):  
Analytical Method ◽  
Anhydrous Sodium Sulfate ◽  
Hplc Method ◽  
Array Detector ◽  
Photodiode Array Detector ◽  
Photodiode Array ◽  
Precision And Accuracy ◽  
Hplc Grade Acetonitrile ◽  
Development And Validation

Abstract An easy and simple analytical method was standardized and validated for the estimation of residues of spirotetramat and its metabolite spirotetramat cis enol in various substrates: okra fruits, brinjal leaves and fruits, green chili, red chili, and soil. The samples were extracted with acetonitrile, diluted with brine solution, partitioned into dichloromethane, dried over anhydrous sodium sulfate, and cleaned up by treatment with activated charcoal powder. Final clear extracts were concentrated under vacuum and reconstituted with HPLC grade acetonitrile. Residues were estimated using HPLC with a photodiode array detector and a C18 column, and confirmed by HPTLC. Acetonitrile was used as the mobile phase at 0.4 mL/min. Both spirotetramat and spirotetramat cis enol presented distinct peak at retention times of 8.518 and 7.598 min, respectively. Consistent recoveries ranging from 82 to 97% for spirotetramat and spirotetramat cis enol were observed when samples were spiked at 1.00 to 0.03 mg/kg levels. The LOQ of the method was found to be 0.03 mg/kg. The analytical method was validated in terms of parameters, including selectivity, linearity, precision, and accuracy.

Development and Validation of a Green Analytical Method for the Determination of Norfloxacin in Raw Material by FTIR Spectrophotometry

2016 ◽  
Vol 99 (6) ◽  
pp. 1533-1536 ◽  
Author(s):  
Jéssica Sayuri Hisano Natori ◽  
Eliane Gandolpho Tótoli ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Urinary Tract ◽  
Organic Solvents ◽  
Analytical Method ◽  
Environmentally Friendly ◽  
Raw Material ◽  
Waste Generation ◽  
Ftir Spectrophotometry ◽  
Tract Infections ◽  
Development And Validation

Abstract Norfloxacin is a broad-spectrum antimicrobial agent, widely used in humans and animals for the treatment of urinary tract infections. It is a second-generation fluoroquinolone. Several analytical methods to analyze norfloxacin have been described in the literature. However, most of them are complex and require the use of large amounts of organic solvents. This paper describes the development and validation of a green analytical method for the determination of norfloxacin in raw material by FTIR spectrophotometry. This method does not require the use of organic solvents, minimizing waste generation in the process and its environmental impacts. The development of methods that promote the reduction, prevention, or elimination of waste generation has become highly attractive to the pharmaceutical industry because of the growing demand from civil society and government authorities for environmentally friendly products and services. The FTIR spectrophotometry method was validated according to International Conference on Harmonization guidelines, showing adequate linearity (r = 0.9936), precision, accuracy, and robustness. This validated method can be used as an environmentally friendly alternative for the quantification of norfloxacin in raw material in QC routine analysis.

scholarly journals Oxcarbazepine: validation and application of an analytical method

2010 ◽  
Vol 46 (2) ◽  
pp. 265-272 ◽  
Author(s):  
Paula Cristina Rezende Enéas ◽  
Renata Barbosa de Oliveira ◽  
Gerson Antônio Pianetti
Keyword(s):  
Spectrophotometric Method ◽  
Analytical Method ◽  
Disintegration Time ◽  
International Conference ◽  
Pharmacopoeial Monograph ◽  
Development And Validation ◽  
Excipient Compatibility

Oxcarbazepine (OXC) is an important anticonvulsant and mood stabilizing drug. A pharmacopoeial monograph for OXC is not yet available and therefore the development and validation of a new analytical method for quantification of this drug is essential. In the present study, a UV spectrophotometric method for the determination of OXC was developed. The various parameters, such as linearity, precision, accuracy and specificity, were studied according to International Conference on Harmonization Guidelines. Batches of 150 mg OXC capsules were prepared and analyzed using the validated UV method. The formulations were also evaluated for parameters including drug-excipient compatibility, flowability, uniformity of weight, disintegration time, assay, uniformity of content and the amount of drug dissolved during the first hour.

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