Abstract
A simple, precise and accurate stability indicating RP-HPLC method was developed for the estimation of Alcaftadine in bulk drug and its ophthalmic dosage form. Chromatographic separation of target analyte and degradation products was achieved using Enable HPLC ODS C18 G (250 × 4.6 mm, 5 μm) column and mobile phase comprising of methanol: water, 50:50% v/v at a flow rate of 1.2 ml/min with UV detection at 282 nm. The correlation coefficient (r2) was found to be 0.999 in the concentration range of 1-16 μg/ml. The retention time was found to be 3.15 min. The limit of detection and limit of quantitation was found to be 0.25 μg/ml and 0.75 μg/ml respectively. Stress degradation of Alcaftadine was carried out under stress conditions like acid and base hydrolysis, oxidation, thermal and photolytic stress. The degradation products generated as a result of stress did not show any interference to the detection of Alcaftadine. The developed method was validated, and selectivity of the method was demonstrated by its ability to quantify the target analyte in presence of its degradation products.
Highlights
The IUPAC name of Alcaftadine is 6,11-dihydro-11-(1methyl-4-piperidinylidene)-5H-imidazo [2, 1-b][3] benzazepine-3carboxaldehyde (Figure 1)
Alcaftadine is an ophthalmic dual-acting H1-antihistamine and mast cell stabilizer approved for the prevention of itching associated with allergic conjunctivitis
A literature survey on Alcaftadine revealed that, until now no analytical method was reported for its determination in bulk drug and its ophthalmic dosage form
Summary
The IUPAC name of Alcaftadine is 6,11-dihydro-11-(1methyl-4-piperidinylidene)-5H-imidazo [2, 1-b][3] benzazepine-3carboxaldehyde (Figure 1). The drug was approved by USFDA in July 2010. It is commercially marketed under the name LASTACAFT. Topically administered H1 receptor antagonist containing Alcaftadine for ophthalmic use [1,2]. A literature survey on Alcaftadine revealed that, until now no analytical method was reported for its determination in bulk drug and its ophthalmic dosage form. A clinical pharmacological review report found during the survey showed that liquid chromatography with tandem mass spectrometry (LC/MS/MS) was used to quantitate concentrations of Alcaftadine and R90692 (active metabolite) in K3 EDTA human plasma [3]. It was found that the metabolic fate of 14 C- Alcaftadine was determined by high performance liquid chromatography-based separation of parent compound from metabolites [4]. Since literature did not cite any method for determination of this drug from bulk drug as well as its formulation it was planned to develop a RP-HPLC method to determine alcftadine in presence of its degradation products
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