Pharm Sci. 2017;23(4):271-277.
doi: 10.15171/PS.2017.40

Scopus id: 85040534077
  Abstract View: 386
  PDF Download: 618

Research Article

A Comparative In-Vitro Study for Evaluation of Physicochemical Properties of the Domestic and Innovator Brands of Sertraline Hydrochloride Tablets Available in the Iranian Market

Ali Dastgiri 1,2, Mohammadreza Siahi 2, Elnaz Tamizi 2,3 * ORCiD

1 Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.
2 Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
3 Pharmaceutical Analysis Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

Abstract

Background: The present study was aimed to assess the quality of Iranian and innovator sertraline hydrochloride (SER) tablets available in the Iranian market. This study could make it possible to provide adequate evidences confirming the similar physicochemical quality of Iranian and imported SER products and could subsequently decrease the therapy costs owing to the more affordable costs of Iranian medicines compared to the imported ones. Methods: Seven products including one imported and six Iranian SER tablet brands were purchased from local pharmacy stores in Tabriz. Quantification of the amount of active ingredient in assay, uniformity of dosage units and dissolution tests were performed using an HPLC method recommended by USP monograph and other physicochemical properties were assessed in accordance with the USP general recommendations. Results: According to the obtained results, the amount of active ingredient in all the products met the acceptable range (%90 - %110); the content of all the studied products was uniform (AV ≤ 15); and all the products passed the dissolution test at the first stage (Q30 ≥ 85 %); the average weight of all the products was uniform with RSD% of less than 5%; except for one product with friability of 15.8% (due to the coating issue), all products' hardness (≤ 10 Kg) and friability (≤ 1%) were acceptable and all of them completely disintegrated after 30 min. Conclusion: The results of this study illustrated the acceptable quality of the most Iranian brands of SER compared to the innovator brand regarding the studied physicochemical properties.
First name
 
Last name
 
Email address
 
Comments
 
Security code


Article Viewed: 386

Your browser does not support the canvas element.


PDF Downloaded: 618

Your browser does not support the canvas element.

Submitted: 24 Jun 2017
Accepted: 06 Sep 2017
First published online: 30 Dec 2017
EndNote EndNote

(Enw Format - Win & Mac)

BibTeX BibTeX

(Bib Format - Win & Mac)

Bookends Bookends

(Ris Format - Mac only)

EasyBib EasyBib

(Ris Format - Win & Mac)

Medlars Medlars

(Txt Format - Win & Mac)

Mendeley Web Mendeley Web
Mendeley Mendeley

(Ris Format - Win & Mac)

Papers Papers

(Ris Format - Win & Mac)

ProCite ProCite

(Ris Format - Win & Mac)

Reference Manager Reference Manager

(Ris Format - Win only)

Refworks Refworks

(Refworks Format - Win & Mac)

Zotero Zotero

(Ris Format - FireFox Plugin)