Intrinsic Stability Study and Forced Degradation Profiling of Olopatadine Hydrochloride by RP-HPLC-DAD-HRMS Method
Journal Title: Turkish Journal of Pharmaceutical Sciences - Year 2019, Vol 16, Issue 4
Abstract
Objectives: Forced degradation determines the intrinsic stability of a molecule by establishing degradation pathways in order to identify the likely degradation products (DPs). The objective of the present research was to establish intrinsic stability and forced degradation profiling of olopatadine hydrochloride. Materials and Methods: The intrinsic stability of olopatadine hydrochloride was evaluated by RP-HPLC, where a mixture of 0.1% formic acid and organic phase (methanol:acetonitrile; 50:50 % v/v) was used as mobile phase at 1.0 mL/min in gradient mode. Different stress conditions were employed to explore the intrinsic stability of olopatadine hydrochloride. Results: In acidic condition, five DPs, i.e. OLO1, OLO2, OLO3, OLO4, and OLO5, were observed. OLO5 was the major DP that increased with time and the peak area of OLO was decreased. In addition to OLO3 and OLO5, two more DPs were observed in alkaline condition, i.e. OLO6 and OLO7. OLO5 and OLO6 were two major DPs; OLO5 increased with time while OLO6 had a zigzag pattern of peak area with time. All DPs of neutral condition were also found in acidic condition while OLO3 and OLO5 were common in all three types of hydrolytic degradation. Conclusion: Thus, OLO has similar pattern of degradation profiling in all hydrolytic conditions (acidic, alkaline, and neutral). No degradation was found in thermal, ultraviolet light, or oxidative conditions over 10 days. OLO-Imp was recognized as an analogue structure of OLO and proposed as 11-[(3-dimethylamino)-propylidene]-6,11-dihydro-dibenz[b,e]oxepin-2-propanoic acid in standard drug. OLO1 was identified as (2-(4-(dimethylamino) butyl) phenyl)methanol, which may be formed by cleavage of the tricyclic ring in neutral condition.
Authors and Affiliations
Pawan Kumar BASNIWAL, Deepti JAIN
Keywords
Related Articles
- EP ID EP670148
- DOI 10.4274/tjps.galenos.2018.83007
- Views 134
- Downloads 0
Formulation Design of Hydrocortisone Films for the Treatment of Aphthous Ulcers
Objectives: Research and development in oral drug delivery has evolved to the changeover of solid dosage forms from tablets to oral films. These films offer an elegant route for systemic drug delivery, with an advantage...
Quantification of Galantamine in Sternbergia Species by High Performance Liquid Chromatography
Objectives: This study describes the qualitative and quantitative analysis of galantamine in Sternbergia species growing in Turkey. Materials and Methods: Galantamine was isolated from Sternbergia fischeriana bulbs and t...
Biopharmaceutical Process of Diclofenac Multi-particulate Systems for Chronotherapy of Rheumatoid Arthritis
Objectives: Diclofenac exhibits limited solubility, low bioabsorption and gastric toxicity. The objective of the study was to address the above limitations and to design a multi-particulate formulation for the chronother...
An In Vitro Study on the Cytotoxicity and Genotoxicity of Silver Sulfide Quantum Dots Coated with Meso-2,3-dimercaptosuccinic Acid
Objectives: Silver sulfide (Ag2S) quantum dots (QDs) are highly promising nanomaterials in bioimaging systems due to their high activities for both imaging and drug/gene delivery. There is insufficient research on the to...
Pharmacological and Toxicological Properties of Eugenol
Eugenol is a volatile phenolic constituent of clove essential oil obtained from Eugenia caryophyllata buds and leaves. It is a functional ingredient of numerous products which have been used in the pharmaceutical, food a...