Display options
Cite
Singh R, Shakya AK, Naik R, et al. Stability-indicating HPLC determination of gemcitabine in pharmaceutical formulations. Int J Anal Chem. 2015;2015:862592doi: 10.1155/2015/862592.
Singh, R., Shakya, A. K., Naik, R., & Shalan, N. (2015). Stability-indicating HPLC determination of gemcitabine in pharmaceutical formulations. International journal of analytical chemistry, 2015862592. https://doi.org/10.1155/2015/862592
Singh, Rahul, et al. "Stability-indicating HPLC determination of gemcitabine in pharmaceutical formulations." International journal of analytical chemistry vol. 2015 (2015): 862592. doi: https://doi.org/10.1155/2015/862592
Singh R, Shakya AK, Naik R, Shalan N. Stability-indicating HPLC determination of gemcitabine in pharmaceutical formulations. Int J Anal Chem. 2015;2015:862592. doi: 10.1155/2015/862592. Epub 2015 Mar 08. PMID: 25838825; PMCID: PMC4370102.
Copy Download .nbib Format: NLM
Share it on

Int J Anal Chem. 2015;2015:862592. doi: 10.1155/2015/862592. Epub 2015 Mar 08.

Stability-indicating HPLC determination of gemcitabine in pharmaceutical formulations.

International journal of analytical chemistry

Rahul Singh, Ashok K Shakya, Rajashri Naik, Naeem Shalan

Affiliations

  1. Faculty of Pharmacy, Integral University, Kursi Road, Lucknow 226-026, India.
  2. Faculty of Pharmacy and Medical Sciences, Al-Ahliyya Amman University, P.O. Box 263, Amman 19328, Jordan.

PMID: 25838825 PMCID: PMC4370102 DOI: 10.1155/2015/862592

Abstract

A simple, sensitive, inexpensive, and rapid stability indicating high performance liquid chromatographic method has been developed for determination of gemcitabine in injectable dosage forms using theophylline as internal standard. Chromatographic separation was achieved on a Phenomenex Luna C-18 column (250 mm × 4.6 mm; 5μ) with a mobile phase consisting of 90% water and 10% acetonitrile (pH 7.00 ± 0.05). The signals of gemcitabine and theophylline were recorded at 275 nm. Calibration curves were linear in the concentration range of 0.5-50 μg/mL. The correlation coefficient was 0.999 or higher. The limit of detection and limit of quantitation were 0.1498 and 0.4541 μg/mL, respectively. The inter- and intraday precision were less than 2%. Accuracy of the method ranged from 100.2% to 100.4%. Stability studies indicate that the drug was stable to sunlight and UV light. The drug gives 6 different hydrolytic products under alkaline stress and 3 in acidic condition. Aqueous and oxidative stress conditions also degrade the drug. Degradation was higher in the alkaline condition compared to other stress conditions. The robustness of the methods was evaluated using design of experiments. Validation reveals that the proposed method is specific, accurate, precise, reliable, robust, reproducible, and suitable for the quantitative analysis.

References

  1. J Chromatogr B Analyt Technol Biomed Life Sci. 2003 Jul 5;791(1-2):103-9 - PubMed
  2. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 May 1;835(1-2):136-42 - PubMed
  3. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Aug 7;840(1):44-9 - PubMed
  4. Farmaco. 2004 May;59(5):425-9 - PubMed
  5. Acta Pharmacol Sin. 2004 Dec;25(12):1584-9 - PubMed
  6. J Chromatogr B Analyt Technol Biomed Life Sci. 2003 Feb 25;785(1):65-72 - PubMed
  7. J Mass Spectrom. 2008 Feb;43(2):216-23 - PubMed
  8. J Pharm Sci. 2000 Jul;89(7):885-91 - PubMed
  9. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Apr 5;802(2):263-70 - PubMed
  10. Rapid Commun Mass Spectrom. 2007;21(14):2312-22 - PubMed
  11. J Chromatogr B Biomed Appl. 1995 Mar 10;665(1):171-81 - PubMed
  12. Curr Drug Targets. 2013 Aug;14(9):1061-9 - PubMed
  13. J Sep Sci. 2007 Aug;30(12):1811-20 - PubMed
  14. J Liposome Res. 2012 Dec;22(4):263-9 - PubMed
  15. J Am Pharm Assoc (Wash). 1999 Jul-Aug;39(4):509-13 - PubMed
  16. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Oct 15;858(1-2):71-8 - PubMed
  17. J Pharm Biomed Anal. 2014 Sep;98:371-8 - PubMed
  18. Anal Bioanal Chem. 2010 Dec;398(7-8):3033-42 - PubMed
  19. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Mar 1;847(2):142-52 - PubMed
  20. J Pharm Sci. 1994 May;83(5):716-9 - PubMed

Publication Types