Development of a simple spectrophotometric method for propylene glycol detection in tablets.
A simple spectrophotometric procedure was developed and validated to indirectly assess the quantities of propylene glycol (PG) remaining in compressed liquid/powder admixtures. Such simplified quantitation may facilitate several testing procedures related to various aspects of formulation development and material testing of pharmaceutical powder excipients using various nonvolatile liquids as the diluents. In the present study, this new and simple approach for PG quantitation was developed as an integral part of a new method termed the liquisolid compressibility (LSC) test, used to characterize the compaction behavior of powder excipients. According to LSC testing, several admixtures of a nonvolatile liquid (in this case PG) and a powder, differing in their PG/powder weight ratio, are compressed in order to assess their compactabilities. The PG content of such compacts may then be directly quantitated by the USP gas chromatographic method or, indirectly, by this new simple spectrophotometric procedure. The new approach involves the addition of a dye marker to the PG prior to its incorporation into the powder. After compression, the PG amount remaining in the compacts may be determined by simply extracting the dye from the tablets and analyzing the extracts spectrophotometrically. In this manner, the dye content thus obtained may be extrapolated to the respective net amount of PG originally added as a dye/PG solution to the powder. Statistical comparison of the results obtained from both methods revealed almost absolute correlation.
Grover
R
R
Division of Pharmaceutics and Industrial Pharmacy, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, NY 11201, USA.
Spireas
S
S
Lau-Cam
C
C
D002482:Cellulose / Q000032:analysis; D002849:Chromatography, Gas; D004396:Coloring Agents; D004339:Drug Compounding; D005079:Excipients; D007785:Lactose / Q000032:analysis; D011208:Powders; D019946:Propylene Glycol / Q000032:analysis*; D012822:Silicon Dioxide / Q000032:analysis; D013053:Spectrophotometry; D013607:Tablets
D004396:Coloring Agents; D005079:Excipients; D011208:Powders; D013607:Tablets; D019946:Propylene Glycol; D012822:Silicon Dioxide; D002482:Cellulose; D007785:Lactose