DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE AND PARACETAMOL IN COMBINED TABLET DOSAGE FORM
Abstract
A stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been developed for the determination of simultaneous determination of Enalapril maleate (ENAL), Hydrochlorothiazide (HCTZ) and Paracetamol (PARA) in tablet dosage forms, The separation was achieved on TLC aluminum plates precoated with silica gel 60F-254 using chloroform: methanol: toluene : ethyl acetate (20:10:40:30 % v/v/v/v) as the mobile phase. The densitometric analysis was carried out at 230 nm. Compact bands appeared at Rf 0.21 ± 0.01, 0.50 ± 0.02 and 0.73 ± 0.01 respectively, for ENAL, HCTZ and PARA. Linear regression analysis revealed linearity in the range of 1000 – 6550 ng/spot for ENAL, 100-3600 ng/spot for HCTZ and 500 – 3400 ng/spot for PARA. Drugs were subjected to acid and alkali hydrolyses, forced oxidation, thermal and photo degradation treatments. The degraded products were well separated from the pure drugs. Statistical analysis proved that the method is precise, accurate, selective and economical and may be used for routine analysis of ENAL, HCTZ and PARA in tablet dosage forms.
DOI
https://doi.org/10.22270/jddt.v7i7.1599References
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