Stability study of furans, glucose and xylose under overliming conditions: Effect of sugar degradation products

2021 ◽  
pp. 100722
Author(s):  
Jeanne Andary ◽  
Jaqueline Maalouly ◽  
Rosette Ouaini ◽  
Hanna Chebib ◽  
Douglas N. Rutledge ◽  
...  
Keyword(s):  
Degradation Products ◽  
Stability Study ◽  
Sugar Degradation

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF β-ACETYLDIGOXIN

2016 ◽  
Vol 9 (1) ◽  
pp. 54
Author(s):  
Megha Sharma ◽  
Neeraj Mahindroo
Keyword(s):  
High Performance ◽  
Degradation Products ◽  
Hplc Method ◽  
Stability Study ◽  
Array Detector ◽  
Forced Degradation ◽  
Simple Method ◽  
Stability Indicating ◽  
Rp Hplc

Objective: The objective of the present study was to develop and validate a novel stability indicating reverse phase-high performance liquid chromatography (RP-HPLC) method for determination of β-acetyldigoxin, an active pharmaceutical ingredient (API).Methods: The chromatographic separation was carried out on Agilent Technologies 1200 series HPLC system equipped with photo diode array detector and C-18 (4.6x250 mm, 5 µ) column. The mobile phase consisted of water: acetonitrile (65:35 v/v), delivered at a flow rate of 1.5 ml/min and eluents were monitored at 225 nm.Results: The retention time of β-acetyldigoxin was 9.2 min. The method was found to be linear (R2= 0.9995) in the range of 31.25-500 µg/ml. The accuracy studies showed the mean percent recovery of 101.02%. LOD and LOQ were observed to be 0.289 µg/ml and 0.965 µg/ml, respectively. The method was found to be robust and system suitability testing was also performed. Forced degradation analysis was carried out under acidic, alkaline, oxidative and photolytic stress conditions. Significant degradation was observed under tested conditions, except for oxidative condition. The method was able to separate all the degradation products within runtime of 20 min and was able to determine β-acetyldigoxin unequivocally in presence of degradation products.Conclusion: The novel, economic, rapid and simple method for analysis of β-acetyldigoxin is reported. The developed method is suitable for routine quality control and its determination as API, and in pharmaceutical formulations and stability study samples.

Development and Validation of Stability Indicating High-Performance Thin-Layer Chromatographic (HPTLC) Method for Quantification of Asiaticoside from Centella asiatica L. and its Marketed Formulation

2019 ◽  
Vol 102 (4) ◽  
pp. 1014-1020
Author(s):  
Lisa J Patel ◽  
Manan A Raval ◽  
Samir G Patel ◽  
Archita J Patel
Keyword(s):  
High Performance ◽  
Degradation Products ◽  
Degradation Kinetics ◽  
Centella Asiatica ◽  
Stability Study ◽  
Cns Disorders ◽  
Marker Compound ◽  
Plant Powders ◽  
Development And Validation ◽  
Hptlc Method

Abstract Background: Ayurvedic medicines help in healing disease with fewer undesirable effects in comparison with an allopathic system of medicine to treat central nervous system (CNS) disorders, as the latter is more expensive. Centella asiatica L. is often used in Ayurvedic formulations for the treatment of CNS disorders. Objective: A stability test using an HPTLC method for the estimation of an important marker asiaticoside (ASI) from C. asiatica powder and marketed formulation was developed. Methods: The marker compound ASI from plant powders and marketed formulations were resolved using toluene–ethyl acetate–methanol–glacial acetic acid (2+7+3+1, v/v/v/v) as the mobile phase and then was derivatized. The plant powder and marketed formulation were also subjected to stability studies. Results: The Rf value of ASI was found in range of 0.43–0.47 for the standard ASI, plant powder, and marketed formulation. It was found that the plant powder and formulation exhibited first-order degradation kinetics. Conclusions: The contents of ASI in the formulation (Churna) and its flow characters reduced at the end of the 6 months during an accelerated stability study. The developed method can be used to quantify ASI in the presence of its degradation products. Highlights: The developed method helps in determining batch to batch variation in the content of ASI in herbal formulations.

Stability-indicating UPLC-PDA Method for Ambrisentan Tablets and Identification of a Main Degradation Product by UPLC-MS/MS

2019 ◽  
Vol 16 (1) ◽  
pp. 55-63
Author(s):  
Rodolfo Ortigara ◽  
Martin Steppe ◽  
Cássia Virginia Garcia
Keyword(s):  
Degradation Product ◽  
Degradation Products ◽  
Stability Study ◽  
Drug Degradation ◽  
Mode Waters ◽  
System Suitability ◽  
Main Degradation Product ◽  
Pulmonary Arterial ◽  
Gradient Mode ◽  
Drug Quality Control

Background: Ambrisentan is a drug used to treat the pulmonary arterial hypertension symptoms, commercialized as coated tablets. Drug quality control is an essential part for the development and release of drugs for consumption; however, there are few studies related to the proposition of analytical methods and stability study for ambrisentan. Objective: The development of an UPLC assay of ambrisentan in tablets with degradation product`s elucidation was proposed. Methods: Tests with different solvents and chromatographic columns were carried out, achieving an optimal condition using mobile phase in gradient mode, Waters® BEH C18 column and detection at 260 nm. Results: Satisfactory system suitability was obtained (theoretical plates, sensitivity and resolution among peaks), with a reduced analysis time (6 minutes). The method was validated in accordance with the international guidelines and it demonstrated adequate specificity, either for the drug assay as for the identification and quantification of degradation product. It showed linearity (r= 0.999), accuracy (degradation products recovery: 98.47 - 102.44; assay recovery: 99.98 - 104.32%) and precision (RSD: 0.69), with limits of quantification and detection in suitable magnitude in order to evaluate possible drug degradation. Conclusion: UPLC method demonstrated to be fast with satisfactory robustness. The main ambrisentan degradation product formed under thermal stress conditions was elucidated by UPLC-MS/MS and its structure was suggested.

scholarly journals Determination of Rosuvastatin in the Presence of Its Degradation Products by a Stability-Indicating LC Method

2005 ◽  
Vol 88 (4) ◽  
pp. 1142-1147 ◽  
Author(s):  
Tushar N Mehta ◽  
Atul K Patel ◽  
Gopal M Kulkarni ◽  
Gunta Suubbaiah
Keyword(s):  
Degradation Products ◽  
Stability Study ◽  
Tablet Formulation ◽  
Assay Method ◽  
Forced Degradation ◽  
Degradation Study ◽  
Stability Indicating ◽  
Degraded Samples ◽  
Accelerated Stability

Abstract A forced degradation study was successfully applied for the development of a stability-indicating assay method for determination of rosuvastatin Ca in the presence of its degradation products. The method was developed and optimized by analyzing the forcefully degraded samples. Degradation of the drug was done at various pH values. Moreover, the drug was degraded under oxidative, photolytic, and thermal stress conditions. Mass balance between assay values of degraded samples and generated impurities was found to be satisfactory. The proposed method was able to resolve all of the possible degradation products formed during the stress study. The developed method was successfully applied for an accelerated stability study of the tablet formulation. The major impurities generated during the accelerated stability study of the tablet formulation were matches with those of the forced degradation study. The developed method was validated for determination of rosuvastatin Ca, and the method was found to be equally applicable to study the impurities formed during routine and forced degradation of rosuvastatin Ca.

scholarly journals A pH-Stability Study of Phoslactomycin B and Analysis of the Acid and Base Degradation Products

2005 ◽  
Vol 58 (9) ◽  
pp. 573-582 ◽  
Author(s):  
Suparna Das Choudhuri ◽  
Sloan Ayers ◽  
William H Soine ◽  
Kevin A Reynolds
Keyword(s):  
Degradation Products ◽  
Stability Study ◽  
Ph Stability ◽  
Acid And Base

HPLC Method for Monitoring of Degradation Products in Picoplatin Stability Study

2011 ◽  
Vol 73 (S1) ◽  
pp. 131-135
Author(s):  
Jitka Housková ◽  
Michaela Hrdá ◽  
Kamila Syslová ◽  
Petr Novotný ◽  
Petr Kačer
Keyword(s):  
Degradation Products ◽  
Hplc Method ◽  
Stability Study

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.

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