PHYSICOCHEMICAL PROPERTIES OF SOME PAEDIATRIC AND ADULT PRODUCTS OF DIHYDROARTEMISININ-PIPERAQUINE ANTIMALARIAL MARKETED IN NIGERIA
Abstract
The quality indices of dihydroartemisinin–piperaquine (DP) pediatric and adult (DPP and DPA) formulations of antimalarial were assessed. Moisture content, viscosity, total solid for four (DPP) products along with weight uniformity, tablet hardness, friability, disintegration and dissolution for six (DPA) products, were determined. Assay of chemical content was performed using reverse phase high pressure liquid chromatographic (RP-HPLC) with Zorbax Eclipse XDB C8 column (150 x 4.6 mm, 4.6 µm)), UV detection at 220 nm and flow rate of 0.7 mL/min. Acetonitrile: 10 mM ammonium acetate (70:30%, v/v) and tinidazole served as mobile phase and internal standard, respectively. Statistical analysis of data was performed using Minitab statistical software with one-way analysis of variance comparing the parameters among the formulations and confidence interval set at 95%. DPP products showed pH and moisture content within 3.19 to 4.65 units and 2.6 to 4.4%, respectively. Total solid and viscosity values were within 86.2 to 97.2% and 78.5 to 125.8 mPa.s, respectively. DPA products had comparable and satisfactory weight uniformity, hardness, friability and disintegration tests results except for DPA5 and DPA6 which failed the weight uniformity tests featuring tablets with deviation from the mean above 5%. All DPP products passed chemical content test with values within 92.65 to 101.22% while DPA2, DPA4 and DPA5 failed. All DPA products showed poor dissolution characteristics with C40 values below 60% and T70 values above 70 min. All DP products showed varying physicochemical properties that may give differing drug performance in vivo.
Key words: Dihydroartemisinin-piperaquine, antimalarial, physicochemical properties, Chemical content, biopharmaceutical indices.
DOI
https://doi.org/10.22270/jddt.v7i2.1395References
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