Development and validation of a RP-HPLC method for the quantification of sparfloxacin in pharmaceutical dosage forms.

Authors

  • Z Sultan Drug Research Laboratory. Centre for Advanced Research in Sciences, University of Dhaka (Bangladesh)
  • G Zia-Ul-Huda Department of Pharmaceutical Chemistry. Faculty of Pharmacy, University of Dhaka (Bangladesh)
  • A Hossain Department of Pharmaceutical Chemistry. Faculty of Pharmacy, University of Dhaka (Bangladesh)
  • A Mazid Department of Pharmaceutical Chemistry. Faculty of Pharmacy, University of Dhaka (Bangladesh)
  • A Rashid Department of Pharmaceutical Chemistry. Faculty of Pharmacy, University of Dhaka (Bangladesh)

Keywords:

Sparfloxacin, HPLC, method development, validation

Abstract

A rapid and sensitive reversed phase high performance liquid chromatographic method has been developed for quantitative analysis of sparfloxacin in pharmaceutical preparations. The method was validated according to FDA, ICH and USP guidelines with respect to accuracy, precision, specificity and linearity. The method was developed using the mobile phase comprising 1% aqueous solution of acetic acid and acetonitrile in the ratio of 71: 29% (v/v) at a flow rate of 0.7 mL/min over C-8 bonded silica column at ambient temperature. The recovery was found to be more than 97% for each spiked samples of sparfloxacin demonstrative of accuracy of the protocol. Intraday and interday precision of the new method were less than the maximum allowable limit (RSD% 2.0) according to FDA. The method showed linear response with correlation coefficient value of 0.998. Therefore, the method was found to be accurate, reproducible, sensitive and less time consuming, and can be successfully applied for the assay of sparfloxacin formulations.

Downloads

References

Ito T, Otsuki M, Nishino T. In vitro antibacterial activity of Q-35, a new fluoroquinolone. Antimicrob Agents Chemother. 1992; 35:1708-1714.

Thomson KS, Sanders CC, Hayden ME. In vitro studies with five quinolones: evidence-for changes in relative potency as quinolone resistance rises. Antimicrob Agents Chemother. 1991; 35:2329-2334.

Chin NX, Gu JW, Yu KW, Zhang YX, Neu HC. In vitro activity of sparfloxacin. Antimicrob Agents Chemother. 1991; 35:567-557.

Rastogi N, Labrousse V, Goh KS, Carvalho DSJP. Antimycobacterial spectrum of sparfloxacin and its activities alone and in association with other drugs against mycobacterium avium complex growing extracellularly and intracellularly in murine and human macrophages. Antimicrob Agents Chemother. 1991; 35:2473-2480.

Sultan MZ, Lee KM, Moon SS. Antibacterial effect of naturally occurring unsaturated fatty acids from Prunus japonica against Propionibacterium acnes. Orient Pharm Exp Med. 2009; 9: 90-96.

Kahsay G, Egziabher AG. Quality assessment of the commonly prescribed antimicrobial drug, ciprofloxacin tablets, marketed in Tigray, Ethiopia. Momona Ethiopian J Sci. 2010; 2:93-107.

Rahman NN, Ahmad S. Development of quantitative analysis of sparfloxacin by high performance liquid chromatography. Dhaka Univ J Pharm Sci.2007; 6:21-23.

Gupta H, Aqil M, Khar RK, Ali A, Sharma A, Chander P. Development and validation of a stability-indicating RP-UPLC method for the quantitative analysis of sparfloxacin. J Chromatogr Sci. 2010; 48:1-6.

Sreekanth N, Awen BZ, Rao CB, Raju NJ. A new spectrophotometric method development and validation of sparfloxacin in bulk and pharmaceutical dosage forms by sodium dichromate chromogen. Int J Pharmacy Technology. 2010; 2: 465-471.

Sreekanth N, Awen BZ, Rao CB. A new colorimetric determination and validation of sparfloxacin based on ferric nitrate chromogen. Res J Pharm Biol Chem Sci. 2010; 1: 9-13.

Sharma MC, Sharma S. UV-densitometric determination of sparfloxacin and its application to the assay in pharmaceutical dosage forms. J Optoelectron Biomed Materials. 2010; 2:191-195.

Kamles P, Badmanaban R, Patel CN. Development and validation of spectrophotometric methods for the estimation of sparfloxacin in tablet dosage forms. J Chem Pharm Res. 2010; 2:528-532.

United States Pharmacopoeia 30 - National Formulary 25 (USP 30 - NF 25), United States Pharmacopeial Convention, Rockville, MD, 2007.

International Conference on Harmonization: ICH Harmonized Tripartite Guideline- Validation of Analytical Procedures: Text and Methodology Q2 (R1): 2005.

USA Food and Drug Administration, Methods, method verification and validation; Document No.: ORA-Lab. 5.4.5, version No.: 1.5 (2009).

British Pharmacopoeia (BP)-2009, The Stationary Office, London, 2002.

Downloads

Published

2012-03-20

How to Cite

1.
Sultan Z, Zia-Ul-Huda G, Hossain A, Mazid A, Rashid A. Development and validation of a RP-HPLC method for the quantification of sparfloxacin in pharmaceutical dosage forms. Ars Pharm [Internet]. 2012 Mar. 20 [cited 2025 Jul. 9];53(1):11-6. Available from: https://revistaseug.ugr.es/index.php/ars/article/view/4657

Issue

Vol. 53 No. 1 (2012)

Section

Original Articles

License

The articles, which are published in this journal, are subject to the following terms in relation to the rights of patrimonial or exploitation:

  1. The authors will keep their copyright and guarantee to the journal the right of first publication of their work, which will be distributed with a Creative Commons BY-NC-SA 4.0 license that allows third parties to reuse the work whenever its author, quote the original source and do not make commercial use of it.

b. The authors may adopt other non-exclusive licensing agreements for the distribution of the published version of the work (e.g., deposit it in an institutional telematic file or publish it in a monographic volume) provided that the original source of its publication is indicated.

c. Authors are allowed and advised to disseminate their work through the Internet (e.g. in institutional repositories or on their website) before and during the submission process, which can produce interesting exchanges and increase citations of the published work. (See The effect of open access).