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Development and Validation of a Stability-indicating HPTLC Method for Analysis of Antiasthmatic Drugs

Keywords: RP-HPTLC , Levocetirizine dihydrochloride , Montelukast sodium , Stress conditions , validation

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Abstract:

The objective of the present work was to develop a stability-indicating HPTLC method for Montelukastsodium (MTKT) and Levocetirizine dihydrochloride (LCTZ) in the presence of its degradation productsgenerated from forced decomposition studies. Both drugs were subjected to acid, base, peroxide, andphoto degradation. Successful separation of the drugs from the degradation products formed onaluminum-backed silica gel 60 F254 with Ethyl acetate: Methanol: Ammonia (7.0:1.4:0.7 v/v/v) as themobile phase. Densitometric analysis of was performed at 231nm in concentration range 100-1200ng/spot with range of recovery 99.91± 0.91% for MTKT and 50-600 ng/spot with range of recovery99.28± 0.51 % for LCTZ by the HPTLC method. Statistical analysis proved the method to be repeatable,specific, and accurate for estimation of MTKT and LCTZ. It can be used as a stability indicating methoddue to its effective separation of the drugs from its degradation products.

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