VALIDATED NOVEL STABILITY-INDICATING RP-HPLC METHOD FOR ESTIMATION OF BIMATOPROST AND ITS ISOMER FROM BULK DRUG AND OPHTHALMIC SOLUTION

*Suraj D. Jadhav and Santosh R. Butle

ABSTRACT

Bimatoprost (BMT) is novel prostaglandin analogue, chemically related to prostamide F2α useful in eye glaucoma ocular disorder. BMT is optically active due to the presence of chiral centers and exhibit Cis (Z) to Trans (E) isomerism which prompted chiral impurities in bulk drug.These impurities will be carry forward to drug product. In the present study, a simple and economic reversed phase HPLC method was developed for analysis of the BMT and it known chiral impurities in drug substance and drug product. The optimized separation was performed on X-Bridge C18 150mm x 4.6mm, 3.5μ column with isocratic elution by maintaining column temperature at 40 ºC. The mobile phase consisted a simple mixture of water, methanol and acetic acid in the rationof 52:48:01 v/v/v. Detection of analytes was conducted on 210. The stability indicating capability of this method was demonstrated by carrying out forced degradation studies. BMT underwent significant degradation when subjected to acidic and oxidative environment, while BMT is stable in alkali, thermal and photolytic degradation. The degradant did not interfere with BMT and its impurity which is proven by peak purity of each peaks. The performance of this method was validated in accordance to the regulatory guidelines recommended by the International Conference of Homonization (ICH). The stability indicating proposed method in this paper could be applied for process development as well as quality assurance of BMT bulk drug and ophthalmic solution.

Keywords: Bimatoprost, Chiral impurities, RP-HPLC, Method development, Validation, Forced degradation.