FTIR SPECTROPHOTOMETRIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ARTEMETHER AND LUMEFANTRINE IN BULK AND FORMULATIONSAbstract
A FTIR method was developed to estimate Artemether and Lumefantrine simultaneously in bulk as well as in formulations. It is based on the measurement of absorption of radiation at the absorption band of ether at 1113.10-1091.77 cm-1 for ART and phenyl substitution band at 893.65-857.08 cm-1 for LUM, because those absorption bands did not occur in excipients present in a pharmaceutical preparation. The proposed method was validated as per ICH guidelines. The calibration curve was obtained for a series of concentration in the range of 17-470 mg for ART and 10-250 mg for LUM, and it was found to be linear. The linear regression equation was y = +84.78-193.1*x for ART and y = +353.75+2129.1*x for LUM with correlation coefficient value 0.999 for ART and LUM which were within the acceptance criteria. The precision was measured regarding repeatability and % RSD was calculated and was found to be 0.831 for intraday and 0.831 for inter-day precision. Recovery was carried out standard addition method at three different levels which are 80%, 100%, and 120%. The % recovery was calculated and was found to be 99.8 and ± 0.556 for ART and 99.9 ± 0.094 for LUM. The % assay was calculated from the standard calibration curve. The results 99 ± 0.1 for ART and 99.9 ± 0.1 for LUM presented good agreement within the labelled content. Thus the method developed in the present investigation is simple, sensitive, rapid and precise. Hence, the developed method can be successfully applied for the estimation of ART and LUM in bulk and tablet dosage form.
S. S. Prasanth * and S. Rukku
Al-Shifa College of Pharmacy, Kizhattur, Perinthalmanna, Malappuram, Kerala, India.
01 October 2018
28 January 2019
11 February 2019
01 June 2019