QbD APPROACH FOR STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN COMBINED DOSAGE FORM
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.
Indicating High-Performance Liquid
Chromatography Method for the Estimation of
Artemether in Capsule Dosage Forms” JYP, 2010, 1,
2. Patil R, “A Stability-Indicating LC method for
Lumefantrine” Chromatographia, 2009, 1 , 69.
3. Naik FD, Chorawala H, Dedania Z, Vijyendraswamy
SM, Surati J, “Development and Validation of UV
Spectrophometric Methods for Simultaneous
Estimation of Artemether and Lumefantrine in
Synthetic Mixture and Tablet Dosage Form” JPR,
2014, 3(4), 70-73.
4. Naik FD, Chorawala H, Dedania Z, Vijyendraswamy
SM, Surati J, “Development and Validation of
HPTLC Method for Simultaneous Estimation of
Artemether and Lumefantrine in Synthetic Mixture
and Tablet Dosage Form.” PSM, 2014 5(2), 1-7.
5. Mondal P, Satla S and Raparla R, “Novel stability
indicating validated RP-HPLC method for
simultaneous quantification of Artemether and
Lumefantrine in bulk and tablet” CPA, 2014, 10, 4.
6. Suleman S, Kirsten V, Evelien W, Matthias DH,
Bracke N, Luc D, Christian B, Peremans K and Bart
De S, “A rapid stability-indicating, fused-core HPLC
method for simultaneous determination of β-
Artemether and Lumefantrine in anti-malarial fixed
dose combination products” MJ, 2013, 12, 145.
7. Sridhar B, “A validated RP-HPLCmethod for the
simultaneous estimation of Artemether and
Lumefantrine in pharmaceutical dosage forms”
IJAPS, 2010, 1, 201.
8. Mannur V, Mastiholimath V, Patware P, Kharya R
and Mascarenhas R, “Analytical method development
and validation for simultaneous estimation of
Artemether and Lumefantrine in pure and
pharmaceutical dosage form using RP-HPLC
method” MJAS, 2013, 3, 348-358.
9. Sunil J, “HPLC method development and validation
for simultaneous estimation of Artemether and
Lumefantrine in pharmaceutical dosage forms”
IJPPS, 2015, 2, 9396.
10. Rajkotwala A, “QbD approach to analytical method
development and validation of piracetam by HPLC”
WJPR, 2016, 5, 1771-1784.
11. Krishna VM , Dash RN, Reddy BL, Venugopal P ,
Sandeep P and Madhavi G,“Quality by Design (QbD)
approach to develop HPLC method for eberconazole
nitrate: Application to hydrolytic, thermal, oxidative
and photolytic degradation kinetics.” King Saud Uni.
J. Saudi Chem. Soc. 2013, 1,1-10
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