Dissolution test method for rifampicin-isoniazid fixed dose formulations.
A dissolution procedure for a rifampicin-isoniazid combination formulation was evaluated using 0.1 N hydrochloric acid solution and 0.4% (w/v) sodium lauryl sulphate solution as dissolution media. Rifampicin and isoniazid along with degradation components were chromatographed using reversed-phase liquid chromatography on a 10 microns octadecylsilica column using methanol-0.01 M disodium hydrogen phosphate (70:30, v/v; pH 4.6 +/- 0.1) as mobile phase. The detection was carried out at 254 nm. The data obtained indicate that the dissolution medium consisting of 0.4% (w/v) sodium lauryl sulphate solution is suitable for such a combination. The degradation observed in dissolution medium consisting of 0.1 N hydrochloric acid was 10-23%.
Jindal
K C
KC
Lupin Laboratories Limited, M.I.D.C., Aurangabad, India.
Chaudhary
R S
RS
Singla
A K
AK
Gangwal
S S
SS
Khanna
S
S
D002214:Capsules; D002851:Chromatography, High Pressure Liquid; D004338:Drug Combinations; D006801:Humans; D007202:Indicators and Reagents; D007538:Isoniazid / Q000032:analysis* / Q000737:chemistry / Q000493:pharmacokinetics; D012293:Rifampin / Q000032:analysis* / Q000737:chemistry / Q000493:pharmacokinetics; D012995:Solubility; D013056:Spectrophotometry, Ultraviolet
D002214:Capsules; D004338:Drug Combinations; D007202:Indicators and Reagents; D007538:Isoniazid; D012293:Rifampin