Skip to main content
SpringerLink
Log in

Determination of Dutasteride by LC: Validation and Application of the Method

  • Original
  • Published:
Chromatographia Aims and scope Submit manuscript

Abstract

A simple, rapid, and stability-indicating reversed-phase high-performance liquid chromatographic (LC) method for analysis for dutasteride has been successfully developed. Chromatography was performed on a 150 mm × 4.6 mm C18 column with acetonitrile–water 60:40 (v/v) as isocratic mobile phase at 1.0 mL min−1. Ultraviolet detection of dutasteride was at 210 nm. Its retention time was approximately 10 min and its peak was symmetrical. Response was a linear function of concentration over the range 0.2–1 μg mL−1 (R 2 = 0.997) and the limits of detection and quantitation were was 0.05 and 0.10 μg mL−1, respectively. The method was validated for linearity, precision, repeatability, sensitivity, and selectivity. Selectivity was validated by subjecting dutasteride stock solution to photolytic, acidic, basic, oxidative, and thermal degradation. The peaks from the degradation products did not interfere with that from dutasteride. The method was used to quantify dutasteride in pharmaceutical preparations.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7

Similar content being viewed by others

References

  1. GlaxoSmithKline (2002) Avodart: prescribing information. GlaxoSmithKline, North Carolina

    Google Scholar 

  2. Gisleskog PO, Hermann D, Hammarlund-Udenaes M, Karlsson MO (1999) Eur J Pharm Sci 8(4):291–299

    Article  Google Scholar 

  3. Gisleskog PO, Hermann D, Hammarlund-Udenaes M, Karlsson MO (1999) Br J Clin Pharmacol 47(1):53–58

    Article  CAS  Google Scholar 

  4. Ramakrishna NVS, Vishwottam KN, Puran S (2004) J Chromatogr B 809:117–124

    Article  CAS  Google Scholar 

  5. Gregory S, Merrick W, Butler M (2006) Urology 68(1):116–120

    Article  Google Scholar 

  6. Xu Y, Susan L, Dalrymple (2006) Clin Cancer Res 12(13):4072–4079

    Article  CAS  Google Scholar 

  7. Makridakis N, Reichardt JKV (2005) J Mol Endocrinol 34(3):617–623

    Article  CAS  Google Scholar 

  8. Guidance for Industry Q1A (R2) Stability testing of new drug substance and products

  9. International Conference on Harmonization (1994) Harmonised tripartite guideline, text on validation of analytical procedures, Q2A. In: International conference on harmonization of technical requirements for registration of pharmaceuticals for human use

  10. International Conference on Harmonization (1996) Harmonised tripartite guideline, text on validation of analytical procedures, Q2B. In: International conference on harmonization of technical requirements for registration of pharmaceuticals for human use

Download references

Author information

Authors and Affiliations

  1. Therapeutic Drug Monitoring Laboratory, 194, Scheme No. 6, Road No. 15, Sion Koliwada, Sion (E), Mumbai, 400 022, India

    Sudhir S. Kamat, Vishal B. Choudhari, Vinayak T. Vele & Swarup S. Prabhune

Authors
  1. Sudhir S. Kamat
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Vishal B. Choudhari
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Vinayak T. Vele
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Swarup S. Prabhune
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Swarup S. Prabhune.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Kamat, S.S., Choudhari, V.B., Vele, V.T. et al. Determination of Dutasteride by LC: Validation and Application of the Method. Chroma 67, 911–916 (2008). https://doi.org/10.1365/s10337-008-0602-x

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1365/s10337-008-0602-x

Keywords

Search

Navigation