Rapid quantitative analysis of magnesium stearate in pharmaceutical powders and solid dosage forms by atomic absorption: method development and application in product manufacturing.
The distribution of magnesium stearate (MgSt) in tablet granule has a significant impact on the compression process. A rapid quantitative method for evaluating magnesium stearate content by atomic absorption was established. The MgSt was extracted from the granule in 0.1 mol/L nitric acid and the resulting free magnesium ion quantitated by atomic absorption. The total analysis time was significantly shortened in comparison to the previously used sample ignition method. This newly established method was evaluated with several drug products and several types of blender. The analytical method was also applied to tablets with poor compression (rough tablet surface). The MgSt content in these rough surface tablets was significantly lower than in tablets with smooth surfaces from the same batch. From these results, this atomic absorption method is considered to be an accurate and useful method for evaluating MgSt distribution and can be applied to tablet manufacturing process validation.
Sugisawa
Keiichi
K
Project Management Group, NPI & Technology Department, GlaxoSmithKline K.K., 506 Dosawa, Nikko-shi, Tochigi 321-1274, Japan. keiichi.2.sugisawa@gsk.com
Kaneko
Takashi
T
Sago
Tsuyoshi
T
Sato
Tomonobu
T
D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding / Q000379:methods*; D007700:Kinetics; D011208:Powders; D015203:Reproducibility of Results; D012995:Solubility; D013054:Spectrophotometry, Atomic; D013229:Stearic Acids / Q000008:administration & dosage / Q000032:analysis*; D013607:Tablets
D011208:Powders; D013229:Stearic Acids; D013607:Tablets; C031183:stearic acid