Application of the experimental design method to photostability studies of Karvileks tablet
1, 2, 1, 3, 4
- 1Faculty of Technology, Univerzity of Nis, Bulevar oslobodjenja 124, Leskovac, Serbia.
- 2Faculty of Pharmacy, Vojvode Stepe 450, Belgrad, Serbia.
- 3Pharmaceutical and Chemical Industry -Zdravlje Actavis, Vlajkova 199, Leskovac, Serbia.
- 4DCP Hemigal, Leskovac, Serbia.
CORRESPONDENCE
Dr Ivana Savic
Department of Pharmaceutics, Faculty of Technology, Bulevar oslobodjenja 124, 16000 Leskovac, Serbia.
Received: 06-07-2011; Accepted: 18-12-2011.
Volume 46, Issue 3 · pp. 275-282 · 2012 · DOI:
ABSTRACT
This study was examined a photostability of Karvileks (Zdravlje-Actavis, Serbia), packed in the different primary packs. For these examination, the experimental design with 3 independent variables: wavelength of radiation (X1), duration of radiation (X2) and type of packs (X3) was applied. After irradiation of Karvileks, the content of carvedilol and its impurities A, B and C was taken as a response (Y1, Y2, Y3, Y4). The obtained mathematical equations can be used for determination of carvedilol and its impurities content in any case. Tablets were packed in an opaque plastic container, as well as in red blister. The content of carvedilol was determined using a stability-indicating RP-HPLC method. The obtained models were: Y1 = 93.11 + 1.74 X1 - 2.19 X2 + 2.01 X3 + 0.39 X1X2 + 0.39 X1X3; Y2 = 0.22 - 0.02 X1 + 0.14 X2 - 0.01X3 - 0.01 X1X2 - 0.007 X2X3 ; Y3 = 0.001 + 0.014 X1 + 0.014 X2 - 0.001X3 + 0.014 X1X2 - 0.001X2X3 ; Y4 = 0.102 + 0.008 X1 + 0.064 X2 - 0.007 X3. By using an experimental design, the opaque plastic container was selected as an adequate primary pack for Karvileks. This pack provides an adequate protection of the preparation from the effect of sunlight.
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Savic, I., Marinkovc, V., Savic, I., Sibinovic, P., & Cekic, N. (2012). Application of the experimental design method to photostability studies of Karvileks tablet. Indian Journal of Pharmaceutical Education and Research, 46(3), 275-282.
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