DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF DARUNAVIR ETHANOLATE IN BULK AND TABLETS

  • Hemant K. Jain Department of Quality Assurance Techniques, STES’s, Sinhgad College of Pharmacy, Vadgaon (Bk.), Pune 411041, Maharashtra, India
  • Umakant S. Jadhav Department of Quality Assurance Techniques, STES’s, Sinhgad College of Pharmacy, Vadgaon (Bk.), Pune 411041, Maharashtra, India
  • Umakant S. Jadhav Department of Quality Assurance Techniques, STES’s, Sinhgad College of Pharmacy, Vadgaon (Bk.), Pune 411041, Maharashtra, India

Abstract

Objective: A new precise, accurate, sensitive and robust RP-HPLC method was developed for estimation of darunavir ethanolate in bulk and tablets.

Methods: The chromatographic separation was achieved on Enable C18 column (250 × 4.6 mm, 5 µm) at an ambient temperature. The mobile phase consists of acetonitrile and 0.01M potassium acetate buffer, pH 5.1 (75:25 v/v) was at the flow rate 1 ml/min and UV detection was done at 268 nm.

Results: The method was linear over the concentration range of 40-90 µg/ml (r2= 0.998) of the drug. The percentage content was found in darunavir ethanolate 99.19±0.58 in tablets. The low value of the drug %RSD (0.11) indicates that reproducibility of this method. Low value of LOD and LOQ suggests the sensitivity of the method.

Conclusion: It can be concluded from the results that the proposed RP-HPLC method was found to be rapid, simple, accurate, robust and precise for the analysis of darunavir ethanolate in bulk and tablet dosage form. The developed method can be applied in routine analysis of this drug in the pharmaceutical industry.

 

Keywords: Darunavir ethanolate, Validation and RP-HPLC

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Author Biography

Hemant K. Jain, Department of Quality Assurance Techniques, STES’s, Sinhgad College of Pharmacy, Vadgaon (Bk.), Pune 411041, Maharashtra, India
Associate professor and Head

References

1. Drug bank. Available from: http: www.drugbank.ca/ drug/db01264. [Last accessed on 2015 Jun 10].
2. Patel BN, Bhanubhai N, Suhagia CN. RP-HPLC method development and validation for estimation of darunavir ethanolate in tablet dosage form. Int J Pharm Pharm Sci 2012;4:270-3.
3. Correa JC, Sera CH, Salgado HR. Stability study of darunavir ethanolate tablets applying a new stability-indicating HPLC method. Chromatogr Res Int 2013;1:1-7.
4. Reddy BV, Jyothi G, Reddy BS, Subhash K, Rambabu C. Stability-indicating HPLC method for the determination of darunavir ethanolate. J Chromatogr Sci 2012;51:471-6.
5. Patel BN, Bhanubhai N, Suhagia CN. A simple and sensitive HPTLC method for quantitative analysis of darunavir ethanolate tablets. J Planar Chromatogr 2011;24:232-5.
6. Ghante MR, Shelar RS, Sawant SD, Kadam MM. Development and validation of spectrophotometric method for estimation of darunavir ethanolate in bulk and tablet dosage form, Int J Pharm Pharm Sci 2014;6:240-2.
7. Jain HK, Ranjale AR. Development and validation of RP-HPLC method for simultaneous estimation of cefoperazone and tazobactam in marketed formulation. Int J Pharm Pharm Sci 2014;6(Suppl 8):462-5.
8. Devkare PN, Jain HK. Development and validation of RP-HPLC method for simultaneous estimation of S(-) amlodipine besylate and clopidogrel bisulphate in tablet dosage form. Int J Pharm Pharm Sci 2013;5(Suppl 3):770-5.
9. Jadhav JS, Vassa SP, Jain HK. Development and validation of a RP-HPLC method for simultaneous determination of pantoprazole and cinitapride in antiulcer formulation. Int J Pharm Pharm Sci 2012;4(Suppl 4):657-9.
10. ICH Harmonized-Tripartite Guidelines. Validation of Analytical Procedure: Text and Methodology Q2 (R1); 2005. p. 1-13.
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How to Cite
Jain, H. K., U. S. Jadhav, and U. S. Jadhav. “DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF DARUNAVIR ETHANOLATE IN BULK AND TABLETS”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 7, no. 11, Sept. 2015, pp. 386-9, https://innovareacademics.in/journals/index.php/ijpps/article/view/7825.
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