GET THE APP

Stability indicating HPLC method for the quantification of bepotastine besilate and its related substances* | Abstract

Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

ISSN: 0975-413X
All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission Systemof respective journal.

Abstract

Stability indicating HPLC method for the quantification of bepotastine besilate and its related substances*

Author(s): Narasimha Reddy Kotla*, Nagaraju Ch VS, Rajan ST, Eshwaraiah S, Sampath Kumar Reddy G, Rakesh M, Seetha Rama Sarma P, Kishore M and Chakravarthy IE

A reverse phase liquid chromatographic (RP-LC) method was developed for the quantification of the related impurities of Bepotastine besilate drug substance. The method was optimized using buffer (prepared by dissolving 1.0mL H3PO4 (85%) taken in 1000mL milli-Q-water and then pH was adjusted to 3.0 with dilute triethylamine solution) as mobilephase-A, and Acetonitrile : Methanol : water in the ratio of 70:20:10 v/v/v as mobile phase-B. The flow rate was set at 1.0 mL min-1, wavelength at 225nm respectively and the column temperature was maintained at 45°C. The capability of stability indicating method developed was demonstrated by studying the degradation products generated during the forced degradation studies under the following conditions i) water hydrolysis, ii) at 75% relative humidity, iii) oxidative, iv) thermal v) photolytic, vi) acid, vii) base, and viii) photolytic degradation. The developed method can be used for the determination of synthetic and degradation impurities in the regular quality control analysis for the drug substance.


PDF

Select your language of interest to view the total content in your interested language

30+ Million Readerbase
SCImago Journal & Country Rank
Google Scholar citation report
Citations : 15261

Der Pharma Chemica received 15261 citations as per Google Scholar report

Der Pharma Chemica peer review process verified at publons
Der Pharma Chemica- Journals on pharmaceutical chemistry