Assessment and validation of green stability indicating RP-HPLC method for simultaneous determination of timolol and latanoprost in pharmaceutical dosage forms using eco-friendly chiral mobile phase

Impurity profiling of active pharmaceutical ingredients is a crucial step in assessing their quality. In this study, a green stability indicating method for simultaneous determination of latanoprost (LTN) and timolol (TIM) was validated and assessed for greenness. TIM & LTN are two anti-glaucoma...

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Bibliographic Details
Published in:Microchemical journal 2019-07, Vol.148, p.21-26
Main Authors: Ibrahim, Adel Ehab, Saleh, Hanaa, Elhenawee, Magda
Format: Article
Language:English
Subjects:
Chiral separation
Green analysis assessment
Latanoprost
Stability indicating
Timolol
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Summary:Impurity profiling of active pharmaceutical ingredients is a crucial step in assessing their quality. In this study, a green stability indicating method for simultaneous determination of latanoprost (LTN) and timolol (TIM) was validated and assessed for greenness. TIM & LTN are two anti-glaucoma drugs manufactured as combination therapy. Their separation was done in presence of their pharmacopeial impurities including LTN C3-epimer using chiral mobile phase additives. Stress conditions were applied to affirm the stability indicating power of the LC-separation. Gradient elution was employed using mixture of aqueous phase (containing 11.35 g β-cyclodextrin and 1.5 g sodium octane sulfonate/L) and the green organic modifier ethanol. Separation was done on monolithic RP-C18 column and 210 nm UV-detection. Elution time was
ISSN:0026-265X
1095-9149
DOI:10.1016/j.microc.2019.04.059