SIZE-EXCLUSION CHROMATOGRAPHIC DETERMINATION OF HYDROXYPROPYL METHYL CELLULOSE AND POLYETHYLENE-GLYCOL-400 IN AN OPHTHALMIC SOLUTION

Hydroxypropyl methyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400) content in HypoTears(TM) Daily Dose ophthalmic solution are dete rmined simultaneously by size exclusion chromatography. The retention times of HPMC and PEG 400 are 10.6 and 15.4 minutes, respectively. The method requires minimal sample pretreatment and is accurate and repro ducible. The peak area response from a refractive index detector versu s HPMC and PEG 400 concentration is linear over the range of 50-150 % of their label claims of 2.5 mg/mL and 10 mg/mL, respectively. The mea n absolute recoveries of HPMC and PEG 400 at their label claim using t he described method are 98.9 +/- 1.3 % and 100.4 +/- 1.2 % (mean +/- S D, n = 12), respectively.