Abstract

A semiautomated spectrophotometric method for the simultaneous determination of pentaerythritol tetranitrate or mannitol hexanitrate and phenobarbital in single tablets is described. The organic nitrate ester component is assayed by a colorimetric procedure involving the diazotization of p-chloroaniline with nitrite formed by alkaline hydrolysis with tetramethylammonium hydroxide and coupling of the resultant compound with N-1-naphthylethylenediamine. The intensity of the color is measured at 570 nm. for pentaerythritol tetranitrate and at 613 nm. for mannitol hexanitrate. Phenobarbital is determined by UV absorption at 241 nm. after extraction into chloroform followed by extraction into aqueous base. The effect of one component on the assay results of the other is reported. Results from the semiautomated method are in agreement within ±3% with those from USP and NF methods. The coefficients of variation for the semiautomated procedure are 1.60, 0.68, and 1.24% for pentaerythritol tetranitrate, mannitol hexanitrate, and phenobarbital, respectively.

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