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A QbD based study in development, optimization and forced degradation behaviour of Epinastine Hydrochloride in Metered dose inhaler by RP-HPLC
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| Author:
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, BIKASH RANJAN.JENA, SIVA PRASAD PANDA, UMASANKAR KULANDAIVELU, RAJASEKHAR REDDY ALAVALA, G.S.N.KOTESWARA. RAO, SURYAKANTA SWAIN, DEBASHISH.GHOSE, DEBI PRASAD PRADHAN
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| Abstract:
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Purpose: Epinastine Hydrochloride is an antihistamine that is applicable in metered dose inhaler as an aerosolized medication to treat respiratory disorders, like COPD and asthma and allergic conjunctivitis etc. An accurate, precise, stability-indicating RP-HPLC method has been developed and validated in its formulations by analytical QbD approach.
Methods: The separation was achieved by Spherisorb 80°A, (C8, 125 mm × 4.0 mm, 5µm) with 210 nm. Optimization of the method has achieved using 22 central composite designs with response surface methodology, which could save time, reagents, and other resources.
Results: A total two independent variables mobile phase composition, and flow rate, were focused to build up, a quadratic model to analyze the effect of variables ahead the observed responses. Optimized conditions include phosphate buffer (10mM KH2PO4) and acetonitrile (60:40 %v/v) as mobile phases with 1.0 ml/min of flow rate. The drug was subjected to various stress degradation studies as per ICH Q2 R1 guidelines.
Conclusion: The AQbD driven RP-HPLC method can be successively employed as a stability-indicating for research laboratories as it could competently separate the drug from its degradation products.
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| Keyword:
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Meter dose inhaler, Validation, Design of Experiment, Andersen cascade impacter, Forced degradation
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.119
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| Download:
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