EurekaMag.com logo
+ Site Statistics
References:
52,725,316
Abstracts:
28,411,598
+ Search Articles
+ Subscribe to Site Feeds
EurekaMag Most Shared ContentMost Shared
EurekaMag PDF Full Text ContentPDF Full Text
+ PDF Full Text
Request PDF Full TextRequest PDF Full Text
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter
Follow on Google+Follow on Google+
Follow on LinkedInFollow on LinkedIn

+ Translate

RP-HPLC stability-indicating assay method for talinolol and characterization of its degradation products


Journal of Chromatographic Science 49(10): 786-795
RP-HPLC stability-indicating assay method for talinolol and characterization of its degradation products
A reversed-phase high-performance liquid chromatographic method is developed and validated for the quantitative determination of talinolol and to characterize its degradation products. A very good resolution between peaks is achieved using a C18 column at 40°C. The mobile phase comprises of a mixture of acetonitrile and potassium dihydrogen orthophosphate buffer (pH 4.4) in the ratio of 27:73 (v/v). The method is validated with respect to linearity, accuracy, precision, robustness, and forced degradation studies, which further proved the stability indicating power. During the forced degradation studies, talinolol is observed to be labile to hydrolytic stress and thermal stress (in the solution form). However, it is stable to the oxidative, photolytic, and thermal stress (in the solid form). The degraded products formed are investigated by electrospray ionization (ESI), time-of-flight mass spectrometry, nuclear magnetic resonance, and infrared spectroscopy. A possible degradation pathway is outlined based on the results. The method is found to be sensitive with a detection limit of 0.125 μg/mL and a quantitation limit of 0.378 μg/mL. The method is also demonstrated to be robust, as it is resistant to small variations of chromatographic variables such as pH, mobile phase composition, flow rate, and column temperature.


Accession: 055338516

PMID: 22080807



Related references

Development and Validation of a Stability-Indicating Assay of Etofenamate by RP-HPLC and Characterization of Degradation Products. Scientia Pharmaceutica 81(4): 1017-1028, 2014

Development of a stability-indicating HPLC method of etifoxine with characterization of degradation products by LC-MS/TOF, 1H and 13C NMR. Journal of Pharmaceutical and Biomedical Analysis 100: 11-20, 2015

HPLC Stability Indicating Assay Method for Metformin Hydrochloride in Bulk Drug and Tablets and Cytotoxicity of Degradation Products. Current Pharmaceutical Analysis 8(4): 368-374, 2012

Development and validation of a stability indicating assay of doxofylline by RP-HPLC ESI-MS/MS, 1H and 13C NMR spectroscopic characterization of degradation products and process related impurities. Journal of Pharmaceutical and Biomedical Analysis 78-79: 92-99, 2013

Development and validation of a stability indicating assay of doxofylline by RP-HPLC: ESI-MS/MS, ¹H and ¹³C NMR spectroscopic characterization of degradation products and process related impurities. Journal of Pharmaceutical and Biomedical Analysis 78-79: 92-99, 2013

LC-MS-MS Characterization of Forced Degradation Products of Fidarestat, a Novel Aldose Reductase Inhibitor: Development and Validation of a Stability-Indicating RP-HPLC Method. Journal of Chromatographic Science 53(9): 1588-1596, 2016

HPLC and LC-MS studies on stress degradation behaviour of tinidazole and development of a validated specific stability-indicating HPLC assay method. Journal of Pharmaceutical and Biomedical Analysis 34(1): 11-18, 2004

Validated stability indicating RP-HPLC for quantitation of nitazoxanide in presence of its alkaline degradation products and their characterization by HPLC-tandem mass spectrometry. Journal of Chromatographic Science 52(9): 1071-1081, 2015

A stability indicating HPLC method for determination of mebeverine in the presence of its degradation products and kinetic study of its degradation in oxidative condition. Research in Pharmaceutical Sciences 9(3): 199-206, 2015

Development and validation of an HPLC stability-indicating method for identification and assay of elemental iron(II) in pharmaceutical drug products using reversed-phase HPLC. Journal of Aoac International 94(4): 1233-1239, 2011