QbD APPROACH FOR STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN COMBINED DOSAGE FORM

  • Pratiksha Singh Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat, India
  • Jenish Maurya Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat, India
  • Zarna Dedania Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat, India
  • Rona Dedania Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat, India

Abstract

The present paper reports a highly selective, sensitive and robust stability indicating RP-HPLC method using QbD
approach, developed and validated for determination of Artemether and Lumefantrine in combined dosage form. The
experimental design describes the scouting of the key HPLC method components including mobile phase and pH.
Their interrelationships are studied and optimized conditions are obtained for each combination of mobile phase and
pH with the help of design expert 10.0 version. Optimal chromatographic conditions were obtained using
Phenomenex, Gemini 5u C-18 column combined with a mixture of Acetonitrile: Buffer (35:65 v/v) mobile phase, pH
adjusted to 2.5 with buffer H3PO4. The flow rate was 1.5ml/min. The injection volume was 10μl. Retention time for
Artemether and Lumefantrine were found 4.44 and 7.84 min respectively. The method was linear with 2-6μg/ml and
12-36μg/ml for Artemether and Lumefantrine respectively. The LOD and LOQ were 0.000278 μg/ml and 0.000841
μg/ml respectively. This method found to have a good percentage recovery in forced degradation study using acid,
base, oxidation, photolytic, thermal and neutral conditions indicates well separation of both the drugs with other
degradation products. All validation parameters were within the acceptance limits.
 

Keywords: QbD, Artemether, Lumefantrine, HPLC, Stability Indicating Analytical Method.

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Author Biographies

Pratiksha Singh, Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat, India

Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat, India

Jenish Maurya, Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat, India

Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat, India

Zarna Dedania, Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat, India

Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat, India

Rona Dedania, Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat, India

Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat, India

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How to Cite
Singh, P., J. Maurya, Z. Dedania, and R. Dedania. “QbD APPROACH FOR STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN COMBINED DOSAGE FORM”. International Journal of Drug Regulatory Affairs, Vol. 5, no. 4, Dec. 2017, pp. 44-59, doi:10.22270/ijdra.v5i4.209.