Development and Validation of a Stability Indicating UV-Visible Spectrophotometer Method for Determination of Methylprednisolone Opthalmic Soltuion

Abstract

The aims of this study were to develop and validate a stability-indicating UV spectrophotometric method for methylprednisolone in extemporaneous ophthalmic preparations; and study the stability of 1% w/v methylprednisolone extemporaneous ophthalmic preparations under 2 storage conditions under ICH guideline. The amount of drug was carried out by using of UV-VIS spectrophotometer at 248 nm. Calibration curve between absorbance and drug concentration was linear with R² 0.999 with the precision (% RSD) of 0.80-1.80, and the accuracy (% recovery) of 100.44-101.20%. Stability of 1% w/v methylprednisolone extemporaneous ophthalmic preparations was studied. Ophthalmic solutions were prepared by dissolving methylprednisolone injection in 0.45% saline solution. The ophthalmic solutions were stored in sterile amber glass bottles at refrigerated temperature (2-8 ºC) and room temperature (30±2 ºC) within 2 months. Physical characteristic changes were observed in ophthalmic solution stored in refrigerator within 67 days. While physical changes of ophthalmic solution after kept at room tem­perature were detected within 10 days. The pH value of solutions was lower than that required by United States Pharmacopeia within 6 and 52 days when stored at room temperature and in refrigerator, respec­tively. However there were still a drug label amount over 90 percent. Conclusion that stability of 1% w/v methylprednisolone extemporaneous ophthalmic preparations was sustained up to 51 days in 2-8 ºC. However, once the bottle was opened the eye drop should be used within 4 weeks.