Development of UV-Spectrophotometric Method for Assessment of Sparfloxacin in Bulk and Pharmaceutical Dosage Forms

Authors

  • Kaushal Kumar  Department of Pharmacy, M.J.P. Rohilkhand University, Bareilly, India
  • Lakshyaveer Singh  Department of Pharmacy, M.J.P. Rohilkhand University, Bareilly, India

Keywords:

Fluorquinolone, sparfloxacin, Quantitative determination, UV, validation

Abstract

The aim of this study was to develop and validation of an UV-spectrophotometric method for the estimation of sparfloxacin in bulk and various pharmaceutical dosage forms using 0.1 N HCl (gastric simulatory media) as per ICH guidelines. The λmax for sparfloxacin in gastric simulatory media was found to be 296 nm. The drug followed linearity at the concentration range of 2-12μg/ml with a correlation coefficient value of 0.999. The devised method was applied onto the bulk and tablets (marketed pharmaceutical formulation) for quantification of contents of drug. Estimated drug was found to be in-between 98.43 to 101.57 % in marketed tablets, a good agreement with the claimed level. The accuracy of the method was verified by recovery experiment performed at three different levels- 75%, 100%, and 125%. The % recovery was found to be in the range of 97.31-101.45%. The accuracy and reproducibility of the method was indicated by low values of % RSD. The precision of the method was studied through intraday and Interday variations and repeatability. The % RSD value< 2 confirmed the precision of developed method. Ruggedness of the proposed method was studied with the help of two analysts. The proposed method was found to be a rapid yet successful tool for routine analysis of sparfloxacin in the bulk and in the pharmaceutical dosage forms.

References

  1. The Merck Index. 12th ed. New Jersey, USA: 8879
  2. Canton E, Peman J, Jimenez MT, Ramon MS, Gobernado M. In vitro activity of sparfloxacin compared with those of five other quinolones. Antimicrob Agent chemother. 1992; 36(3): 558-565.
  3. Kimura M, Kishimoto T, Hashiguchi K, Niki Y, Soejima R. In-vitro and In-vivo activities of sparfloxacin against Chlamydial species. Drugs. 1993; 45(S3):370.
  4. Kocagoz Ss, Gur D, Uzun O, Ozkuyumeu C,Akova M, Akalin HE. Comparative In-vitro activity of sparfloxacin against gram-positive cocci. Drugs. 1993; 45(S3): 199-200.
  5. Andersson MI, MacGowan AP. Development of the quinolones. J Antimicob Chemother. 2003; 51(S1): 1-11.
  6. Marona HRN, Schapoval EES. Spectrophotometric determination of sparfloxacin in pharmaceutical formulations using bromothymol blue. J Pharma biomen Anal. 2001; 26: 501-504.
  7. Sujitha Parimala S*, Asha Jyothi P, Tejaswi K. Spectrophotometric Estimation of Sparfloxacin in Bulk and Tablet Dosage Form. International Journal of Innovative Pharmaceutical Research. 2013,4(2),306-309.
  8. RAHMAN N N, AHMAD S. Development of quantitative analysis of sparfloxacin by high performance liquid chromatography’. Dhaka University Journal of Pharmaceutical Sciences, August 2007:6(1).
  9. Bera A K, De A K, Pal B. Devlopment and validation of a rapid RP-HPLC method for estimation of sparfloxacinin tablet dosage form. International Journal of Pharmaceutical Sciences and Research. 2014; Vol. 5(2): 563-567.
  10. Sharma M C, Sharma S. UV-Densitometric determination of sparfloxacin and its application to the assay in pharmaceutical dosage forms. Journal of Optoelectronics and Biomedical Materials Vol. 2, Issue 4, October-December 2010: 191 – 195.
  11. ICH-Guidelines Q2 (R1), Validation of Analytical Procedures: Text and Methodology. 2005.
  12. United States Pharmacopeia. USP Convention, Rockville, MD, 2008; p 1225.
  13. ICH (Q2, R1).Note for guidance on validation of analytical methods: Definitions and terminology. International conference on harmonization.1994:9-13

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Published

2017-07-30

Issue

Section

Research Articles

How to Cite

[1]
Kaushal Kumar, Lakshyaveer Singh, " Development of UV-Spectrophotometric Method for Assessment of Sparfloxacin in Bulk and Pharmaceutical Dosage Forms , International Journal of Scientific Research in Science and Technology(IJSRST), Online ISSN : 2395-602X, Print ISSN : 2395-6011, Volume 3, Issue 6, pp.867-873, July-August-2017.