Author(s): GIDEON O. OKPANACHI*1, HASSAN MUSA2, YUSUF MOHAMMED2, IFEANYI V. EMENIKE1AND MAHMUD S. GWARZO
Objective: The aim of this research is to determine the quality and uniformity of brands of α-Methyldopa 250 mg tablets marketed in Zaria, Kaduna State, Nigeria. Methods: Eight (8) brands of α-Methyldopa 250 mg tablets labelled as samples A, B, C, D, E, F, G and H were used to ascertain the level of uniformity within each batch and from brand to brand using the quality control tests such as identification test, uniformity of weight test, friability test (FR), crushing strength test (CS), disintegration time test (DT),dissolution test and test uniformity of active content. Results:All the brands of the methyldopa tablets used passed the BP standards for identification test, uniformity of weight, thickness, diameter and friability test but failed CS test except sample A and G, which showed CS within the range of 4-8 Kgf. All the brands except sample G complied with the BP, 2009 specification of DT. Also, all the brands except sample G passed the uniformity of active content test (Assay) specified by the BP, 1980 with little significant difference; A=95.96 %, B=97.98 %, C=102.02 %, D=96.40 %, E=100.89 %, F= 102.92 %, G=46.52 %, and H=97.08 %. Similarly, all the brands complied with the dissolution rate test stipulated by the Indian Pharmacopeia 4th Edition except sample Gwith a significant low dissolution profile after 60 minutes; 95.96 %, 98.01 %, 101.65 %, 95.68 %, 100.69 %, 102.02 %, 42.26 % and 97.16 % for the sample A, B, C, D, E, F, G, and H respectively. Conclusion: There is a considerable degree of uniformity among the brands examined except sample G.
ISSN: 2320-3315
ICV :81.58