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A validated method without derivatization for the determination of Letrozole by high performance liquid chromatography-fluorimetric method for pharmaceutical preparation

Year 2018, Volume: 48 Issue: 2, 38 - 42, 31.08.2018

Abstract

DOI: 10.5152.IstanbulJPharm.2018.397094


A high performance liquid chromatography
method has been developed for determination of letrozole in tablets. The method
has developed in reverse phase column with acetonitrile-50.0 mM phosphoric acid
solution, pH:7 (50:50, v/v) and 0.7 mL/min flow rate by using a fluorimetric
detector. Letrozole has natural fluorescence properties, and there is no need
for derivatization for this molecule. The detector was set at 256, 585 nm for
excitation and emission wavelength respectively. The method was validated in
accuracy, precision, specificity, linearity and system suitability parameters
are studied.  The linear range was found
50-700 ng/mL. The limit of detection and quantification for letrozole was found
to be 14-50 ng/mL respectively. The recovery of drug is found to be 98.8%. The
developed method has been validated and successfully applied to tablet analysis
of drug substance. This method is simple, reproducible and can be used safely
for routine analysis of letrozole in tablets.

References

  • Acharjya S, Mallick P, Panda P, Kumar K, Annapurna M (2010). Spectrophoto¬metric methods for the determination of letrozole in bulk and pharmaceutical dosage forms. J Adv Pharm Technol Res 1(3): 348–353.
  • Annapurnaa M, Mohapatrob C, Narendrab A (2012). Stability-indicating liquid chromatographic method for the determination of letrozole in pharmaceutical formulations. J Pharm Anal 2:298–305.
  • Gomes S, Bhosale S (2013). Application of sensitive rapid and validated liquid chromatography tandem mass spectrometry method for simultaneous determination of letrozole and metformin in hu¬man plasma. Int J Adv Res Pharm Bio Sci 3(2): 84-94.
  • Lamb HM, Adkins JC (1998). Letrozole a review of its use in postmenopausal women with advanced breast cancer. Drugs 56: 1125-1140.
  • Mareck U, Sigmund G, Opfermann G, Geyer H, Thevis M, Schän¬zer W. (2005). Identification of the aromatase inhibitor letrozole in urine by gas chromatography/mass spectrometry. Rapid Commun Mass Spectrom 19(24): 3689-3693.
  • Marfil F, Pineau V, Sioufi A, Godbillon SJ (1996). High-perfor¬mance liquid chromatography of the aromatase inhibitor, le¬trozole, and its metabolite in biological fluids with automated liquid-solid extraction and fluorescence detection. J Chromatogr B Biomed Sci Appl 683: 251-258.
  • Mondal N, Pal TK (2009). Development and validation of RP-HPLC method to determine letrozole in different pharmaceutical for¬mulations and its application to studies of drug release from nanoparticles. Acta Pol Pharm 66(1): 11-17.
  • Moussa B.A, El-Bagary R & Osman E (2013). Determination of letrozole in pharmaceutical preparation and human plasma based on fluorometric detection. Anal Chem Lett 3: 139-146.
  • Nataraj K, Kumar D, Reddy S, Swamy B (2012). Stability indicating method devolopment and validation for related substances for letrozole tablets by RP-HPLC. Res J Pharm, Biol Chem Sci 4, 658-676
  • Pallavi S, Vasanth PM, Ramesh T, Malothu R (2012). Devel¬opment and validation of HPTLC method for the determination of letrozole in bulk and tablet dosage form. Int Res J Pharm 3: 202-204.
  • Prasad H, Govindrajulu G (2012). Forced degradation study of letrozole a validated stability indicating HPLC assay for bulk and tablet dosage form. Int J Pharm Pharm Sci 4(2): 582-586. Prasad H, Govindrajulu G, Palaniyappan V (2012). Forced degradation study of letrozole-A vali¬dated stability indicating HPLC assay for bulk and tablet dosage form. Int J Pharm Pharm Sci 4, 582-586.
  • Rodrígez J, Castañeda G, Muñoz L (2013). Rapid determination of letrozole, citalopram and their metabolites by high performance liquid chromatography-fluorescence detection in urine: Method validation and application to real samples. J Chromatogr B Biomed Sci Appl 913-914: 12-18. Scott LJ, Keam SJ (2006). Letrozole: in postmenopausal hor¬mone-responsive early-stage breast cancer. Drugs 66: 353-62.
  • Zarghi A, Foroutan S, Shafaati A, Khod¬dam A (2007). HPLC Determination of letrozole in plasma using fluorescence detection: Application to pharmacokinetic studies. Chromatographia 66(9): 747–750.
Year 2018, Volume: 48 Issue: 2, 38 - 42, 31.08.2018

Abstract

References

  • Acharjya S, Mallick P, Panda P, Kumar K, Annapurna M (2010). Spectrophoto¬metric methods for the determination of letrozole in bulk and pharmaceutical dosage forms. J Adv Pharm Technol Res 1(3): 348–353.
  • Annapurnaa M, Mohapatrob C, Narendrab A (2012). Stability-indicating liquid chromatographic method for the determination of letrozole in pharmaceutical formulations. J Pharm Anal 2:298–305.
  • Gomes S, Bhosale S (2013). Application of sensitive rapid and validated liquid chromatography tandem mass spectrometry method for simultaneous determination of letrozole and metformin in hu¬man plasma. Int J Adv Res Pharm Bio Sci 3(2): 84-94.
  • Lamb HM, Adkins JC (1998). Letrozole a review of its use in postmenopausal women with advanced breast cancer. Drugs 56: 1125-1140.
  • Mareck U, Sigmund G, Opfermann G, Geyer H, Thevis M, Schän¬zer W. (2005). Identification of the aromatase inhibitor letrozole in urine by gas chromatography/mass spectrometry. Rapid Commun Mass Spectrom 19(24): 3689-3693.
  • Marfil F, Pineau V, Sioufi A, Godbillon SJ (1996). High-perfor¬mance liquid chromatography of the aromatase inhibitor, le¬trozole, and its metabolite in biological fluids with automated liquid-solid extraction and fluorescence detection. J Chromatogr B Biomed Sci Appl 683: 251-258.
  • Mondal N, Pal TK (2009). Development and validation of RP-HPLC method to determine letrozole in different pharmaceutical for¬mulations and its application to studies of drug release from nanoparticles. Acta Pol Pharm 66(1): 11-17.
  • Moussa B.A, El-Bagary R & Osman E (2013). Determination of letrozole in pharmaceutical preparation and human plasma based on fluorometric detection. Anal Chem Lett 3: 139-146.
  • Nataraj K, Kumar D, Reddy S, Swamy B (2012). Stability indicating method devolopment and validation for related substances for letrozole tablets by RP-HPLC. Res J Pharm, Biol Chem Sci 4, 658-676
  • Pallavi S, Vasanth PM, Ramesh T, Malothu R (2012). Devel¬opment and validation of HPTLC method for the determination of letrozole in bulk and tablet dosage form. Int Res J Pharm 3: 202-204.
  • Prasad H, Govindrajulu G (2012). Forced degradation study of letrozole a validated stability indicating HPLC assay for bulk and tablet dosage form. Int J Pharm Pharm Sci 4(2): 582-586. Prasad H, Govindrajulu G, Palaniyappan V (2012). Forced degradation study of letrozole-A vali¬dated stability indicating HPLC assay for bulk and tablet dosage form. Int J Pharm Pharm Sci 4, 582-586.
  • Rodrígez J, Castañeda G, Muñoz L (2013). Rapid determination of letrozole, citalopram and their metabolites by high performance liquid chromatography-fluorescence detection in urine: Method validation and application to real samples. J Chromatogr B Biomed Sci Appl 913-914: 12-18. Scott LJ, Keam SJ (2006). Letrozole: in postmenopausal hor¬mone-responsive early-stage breast cancer. Drugs 66: 353-62.
  • Zarghi A, Foroutan S, Shafaati A, Khod¬dam A (2007). HPLC Determination of letrozole in plasma using fluorescence detection: Application to pharmacokinetic studies. Chromatographia 66(9): 747–750.
There are 13 citations in total.

Details

Primary Language English
Subjects Pharmacology and Pharmaceutical Sciences
Journal Section Original Article
Authors

Cem Kaplan

Durisehvar Ozer Unal This is me

Publication Date August 31, 2018
Submission Date February 20, 2018
Published in Issue Year 2018 Volume: 48 Issue: 2

Cite

APA Kaplan, C., & Unal, D. O. (2018). A validated method without derivatization for the determination of Letrozole by high performance liquid chromatography-fluorimetric method for pharmaceutical preparation. İstanbul Journal of Pharmacy, 48(2), 38-42.
AMA Kaplan C, Unal DO. A validated method without derivatization for the determination of Letrozole by high performance liquid chromatography-fluorimetric method for pharmaceutical preparation. iujp. August 2018;48(2):38-42.
Chicago Kaplan, Cem, and Durisehvar Ozer Unal. “A Validated Method Without Derivatization for the Determination of Letrozole by High Performance Liquid Chromatography-Fluorimetric Method for Pharmaceutical Preparation”. İstanbul Journal of Pharmacy 48, no. 2 (August 2018): 38-42.
EndNote Kaplan C, Unal DO (August 1, 2018) A validated method without derivatization for the determination of Letrozole by high performance liquid chromatography-fluorimetric method for pharmaceutical preparation. İstanbul Journal of Pharmacy 48 2 38–42.
IEEE C. Kaplan and D. O. Unal, “A validated method without derivatization for the determination of Letrozole by high performance liquid chromatography-fluorimetric method for pharmaceutical preparation”, iujp, vol. 48, no. 2, pp. 38–42, 2018.
ISNAD Kaplan, Cem - Unal, Durisehvar Ozer. “A Validated Method Without Derivatization for the Determination of Letrozole by High Performance Liquid Chromatography-Fluorimetric Method for Pharmaceutical Preparation”. İstanbul Journal of Pharmacy 48/2 (August 2018), 38-42.
JAMA Kaplan C, Unal DO. A validated method without derivatization for the determination of Letrozole by high performance liquid chromatography-fluorimetric method for pharmaceutical preparation. iujp. 2018;48:38–42.
MLA Kaplan, Cem and Durisehvar Ozer Unal. “A Validated Method Without Derivatization for the Determination of Letrozole by High Performance Liquid Chromatography-Fluorimetric Method for Pharmaceutical Preparation”. İstanbul Journal of Pharmacy, vol. 48, no. 2, 2018, pp. 38-42.
Vancouver Kaplan C, Unal DO. A validated method without derivatization for the determination of Letrozole by high performance liquid chromatography-fluorimetric method for pharmaceutical preparation. iujp. 2018;48(2):38-42.