ANALYTICAL METHOD DEVELOPMENT & VALIDATION OF ARTEMETHER IN BULK DRUG BY RP- HPLC METHOD AS PER ICH GUIDELINES

  • M. Laxmi Department of Pharmaceutical Analysis & Quality AssuranceNalanda College of Pharmacy, Nalgonda, Andhra Pradesh, India,
  • Somsubhra Ghosh Nalanda College of Pharmacy
  • B. V. V. Ravikumar Department of Pharmaceutical Analysis & Quality Assurance Roland Institute of Pharmaceutical Sciences, Berhampur, Odisha

Abstract

Objective: An accurate, precise, rapid & economical RP-HPLC method was developed for the estimation of Artemether as per International Conference on Harmonization (ICH) guideline in pharmaceutical dosage form using ultraviolet (UV) detector.

Methods: Elution was carried out using a mobile phase consisting of Acetonitrile & Methanol (50:50 v/v) and the flow rate was set to 1.6 ml/min at 216 nm, retention time for Artemether was found to be 1.330 min.

Results: The method was found to be linear in the concentration range of 100-600 µg/ml, in the linearity study regression equation was found to be y = 0.199x – 1.133 & correlation coefficient was found to be 0.999. This method was Rugged and Robust in different testing criteria, LOD and LOQ were found to be 23.037µg/ml, 69.809µg/ml respectively. Accuracy study was done in 3 different concentration level i. e 50, 100, 150% & % recovery of the method was found to be 99.4%, 100.4%, 99.7% respectively in 3 different levels & mean recovery was 99.8%, so method was accurate.

Conclusion: Results of all validation parameters were within the limits as per ICH guidelines.

 

Keywords: HPLC, Validation, Method Development, Artemether, Accuracy, Ptrecission

Downloads

Download data is not yet available.

Author Biography

Somsubhra Ghosh, Nalanda College of Pharmacy
Pharmaceutical Analysis & Quality Assurance.

References

1. Available at: http://www.drugbank.ca/drugs/DB06697
2. Available at: http://www.rxlist.com/coartem-drug/ indications -dosage.htm
3. Kurien J, Kurian T, William H, Vinaya D. Development and Validation of a new reverse Phase HPLC method for the determination of Artemether in pharmaceutical dosage form. J Sci Res Pharm 2014;3(2):64-7.
4. Vandercruyssena K, Matthias D, Hondta, Valentijn, Herwig J. Bart De Spiegeleer CB. LC–UV/MS quality analytics of paediatric artemether formulations. J Pharm Anal 2014;4(1):37–52.
5. Naik FD, Chorawala H, Dedania Zr, Vijyendraswamy SM, Surati J. Development and validation of UV Spectrophotometric methods for simultaneous estimation of Artemether and Lumefantrine in synthetic mixture and Tablet dosage form. J Pharm Res 2014;3(4):70-3.
6. Shah SR, Bapna M, Kunal D, Brahmbhatt R, Patel A, Patel CM. Development and validation of analytical method for simultaneous estimation of Artemether and Lumefantrine in bulk and marketed fixed dose combination. Int J Pharm Sci 2013;4(3):257.
7. Gupta NK, Babu AM, Gupta P. Simultaneous estimation of Artemether and Lumefantrine by RP HPLC method development in pharmaceutical tablet dosage form. Int J Pharm Erud 2013;3(1):10-7.
8. Vinodh M, Vinayak M, Pankaj P, Rahul K, Renita M. Analytical method development and validation for simultaneous estimation of Artemether and Lumefantrine in pure and pharmaceutical dosage form using RP HPLC method. Malay J Anal Sci 2013;17(3):348–58.
9. Terish JD, Suresh Kumar, Ramesh N, Sasi jith SL. Development and validation of high-performance liquid chromatography-tandem mass spectrometric method for simultaneous determination of Artemether and its metabolite, Dihydroartemisinin in human plasma. A pharmacokinetic study application pelagia research library. Eur J Exp Biol 2011;1(3):169-79.
10. Arun R, Smith AA. Simultaneous HPLC-UV method for the estimation of Artemether and Lumefantrine in tablet dosage form. Int J Pharm Biomed Res 2011;2(3):201-5.
11. Rao TB, Krishna MP, Kumar KR, Venkateswarlu P. The forced degradation and solid state stability indicating study and Validation of method for the determination of assay of artesunate by HPLC. Res J Pharm Biol Chem Sci 2011;2(1):111-7.
12. Pawar PY, Manisha P, Chavan, Geetanjali K, Ghanwat, Manish A, et al. Validated spectrophotometric method for quantitative determination of Artemether in pharmaceutical formulation. Der Pharm Chem 2011;3(3):135-9.
13. Kalyankar TM, Kakde RB. Reversed-phase liquid chromatographicmethod for simultaneous determination ofartemether and Lumefantrine in pharmaceutical preparation. Int J Chem Tech Res 2011;3(3):1722-7.
14. Sunil J, Nath MS, Moorthy US. HPLC method development and validation for simultaneous estimation of Artemether and Lumefantrine in pharmaceutical dosage forms. Int J Pharm Pharm Sci 2010;2(4):93-6.
15. Sridhar B, Rao KH, Sai Srinivas TV, Madhuri VS, Madhuri K, Seshagiri Rao JVLN. A validated reverse phase HPLC method for the simultaneous estimation of Artemether and Lumefantrine in pharmaceutical dosage forms. An Int J Adv Pharm Sci 2010;1(1):95.
16. Shrivastava A, Issarani R, Nagori BP. Stability indicating high-performance liquid chromatography method for the estimation of artemether in capsule dosage forms. J Y Pharm 2010;2(1):79-84.
Statistics
1685 Views | 1585 Downloads
How to Cite
Laxmi, M., S. Ghosh, and B. V. V. Ravikumar. “ANALYTICAL METHOD DEVELOPMENT & VALIDATION OF ARTEMETHER IN BULK DRUG BY RP- HPLC METHOD AS PER ICH GUIDELINES”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 7, no. 2, Dec. 2014, pp. 498-01, https://innovareacademics.in/journals/index.php/ijpps/article/view/4062.
Section
Original Article(s)