You are here

Home ยป Content

COMPARATIVE QUALITY ASSESSMENT OF ACETAMINOPHEN IMMEDIATE AND EXTENDED RELEASE TABLETS BY VALIDATED ANALYTICAL METHODS

Journal Name:

  • The International Journal of Pharmaceutical Research and Bio-Science

Publication Year:

  • 2012

Key Words:

Author NameUniversity of Author
Abstract (2. Language): 
In this study quality performance of four immediate release and three extended release acetaminophen tablets were evaluated by using in vitro dissolution and drug content studies. Other general quality parameters of these tablets like weight variation, hardness, friability, disintegration time were also determined according to established protocols. UV spectroscopic and RP-HPLC methods were validated and used to determine the active ingredients in these brands. All the brands complied with the official specification for friability, uniformity of weight, disintegration time and drug content. The results were also subjected to statistical analysis. Potency obtained from UV method and HPLC methods were found similar with statistical t test. Dissolution test results were subjected to further analysis by difference factor (fl), similarity factor (f2), dissolution efficiency (% DE), ANOVA and Bonferroni test. The results indicated that all the immediate release brands are similar in respect of drug release. On the other hand and 2 out of 3 extended release brands are found similar.
Bookmark/Search this post with
FULL TEXT (PDF): 
PDF icon arastirmax-comparative-quality-assessment-acetaminophen-immediate-and-extended-release-tablets-validated-analytical-methods.pdf
  • 3
  • English

REFERENCES

References: 

1. Hsu H, and Ayres JW : J. Pharm. Sci. 1998; 78(10): 844-847.
2.
Hardma
n JG, Limbird LG, Molinoff PB, Ruddeon RW and Gilman AG: Goodman & Gilman's the Pharmacological Basis of Therapeutics. (Electronic version. McGraw-Hill; New York; 2001).
3.
Prescot
t LF: Paracetamol: past, present,
and future. Am J Ther. 2000; 7(2), 143-7.
4.
Sweetma
n SC: Martindale: The Complete Drug Reference; (Electronic version The Pharmaceutical Press; Great
Britain; 2002).
5.
Unite
d States Pharmacopoeia, CD, 30, NF 25, the USP Convention; Rockville
2007.
6.
Britis
h Pharmacopoeia CD version 2; The British Pharmacopoeia Commission;
London; 2009.
7.
Ro
y J, Saha P, Rahman A, and Zakaria
M, J. Inst. Postgrad. Med. Res. 1993; 8 (2): 49-53.
8.
Engl
a G, Maheshwari RK, Agrawall M, and Agrawal A, Int J Chel and Anal Sci.
2010; 1(6): 118-120.
9.
Karthikeya
n V, Vaidhyalingam, Yuvaraj
G, Nema RK, Int J ChemTech Res.2009; 1(3): 457-460.
10. International Conference on Harmonization. Draft Guideline on Validation of Analytical Procedures: 1995. Definitions and Terminology, Federal
Register. 60, 11260.
11. The European Agency for the Evaluation
of Medicinal Products (EMEA), (2001)
Notes for Guidance on the Investigation of Bioavailability and Bioequivalence. Available at http://www.emea.europa.eu/pdfs/human. /ewp/140198en.pdf.
12. US Food and Drug Administration, Center for Drug Evaluation and Research, Guidance for industry: Dissolution testing of immediate release solid oral dosage forms
1997. Available at:
http://www.fda.gov/cder/Guidance/1713bp1.
pdf.
13.
Anderso
n NH, Bauer M, Boussac N, Malek RK, Munden P and Sardaro M: An evaluation of fit factors and dissolution efficiency for the comparison of in vitro dissolution profiles. J. Pharm. Biomed. Anal., 1998, 17 (4-5) 811-822.
Available

Thank you for copying data from http://www.arastirmax.com