QbD APPROACH FOR STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN COMBINED DOSAGE FORM
Journal Title: International Journal of Drug Regulatory Affairs - Year 2017, Vol 5, Issue 4
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.
Authors and Affiliations
Pratiksha Singh, Jenish Maurya, Zarna Dedania, Rona Dedania
Keywords
Related Articles
- EP ID EP329119
- DOI 10.22270/ijdra.v5i4.209
- Views 119
- Downloads 0
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