Determination of rosuvastatin in the presence of its degradation products by a stability-indicating LC method.
A forced degradation study was successfully applied for the development of a stability-indicating assay method for determination of rosuvastatin Ca in the presence of its degradation products. The method was developed and optimized by analyzing the forcefully degraded samples. Degradation of the drug was done at various pH values. Moreover, the drug was degraded under oxidative, photolytic, and thermal stress conditions. Mass balance between assay values of degraded samples and generated impurities was found to be satisfactory. The proposed method was able to resolve all of the possible degradation products formed during the stress study. The developed method was successfully applied for an accelerated stability study of the tablet formulation. The major impurities generated during the accelerated stability study of the tablet formulation were matches with those of the forced degradation study. The developed method was validated for determination of rosuvastatin Ca, and the method was found to be equally applicable to study the impurities formed during routine and forced degradation of rosuvastatin Ca.
Mehta
Tushar N
TN
Torrent Research Center, C/O Torrent Pharmaceutical Ltd., Indira Bridge, Bhat, Gandhinagar, Pin Code 382 428 Gujarat, India. mehtatushar76@rediffmail.com
Patel
Atul K
AK
Kulkarni
Gopal M
GM
Suubbaiah
Gunta
G
D002118:Calcium / Q000737:chemistry; D002845:Chromatography; D002853:Chromatography, Liquid / Q000379:methods*; D004355:Drug Stability; D005464:Fluorobenzenes / Q000032:analysis*; D006358:Hot Temperature; D006851:Hydrochloric Acid / Q000032:analysis; D006863:Hydrogen-Ion Concentration; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000032:analysis; D008027:Light; D010100:Oxygen / Q000032:analysis / Q000737:chemistry; D010919:Placebos / Q000032:analysis; D011743:Pyrimidines / Q000032:analysis*; D015203:Reproducibility of Results; D000068718:Rosuvastatin Calcium; D012972:Sodium Hydroxide / Q000032:analysis; D013449:Sulfonamides / Q000032:analysis*; D013997:Time Factors; D014466:Ultraviolet Rays
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D010919:Placebos; D011743:Pyrimidines; D013449:Sulfonamides; D012972:Sodium Hydroxide; D000068718:Rosuvastatin Calcium; D006851:Hydrochloric Acid; D010100:Oxygen; D002118:Calcium