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

Author(s)

Nilam, P., Shirish, P., Dhara, P.

Author's Affiliation

Abstract

The objective of the present work was to develop a stability-indicating HPTLC method for Montelukast sodium (MTKT) and Levocetirizine dihydrochloride (LCTZ) in the presence of its degradation products generated from forced decomposition studies. Both drugs were subjected to acid, base, peroxide, and photo degradation. Successful separation of the drugs from the degradation products formed on aluminum-backed silica gel 60 F254 with Ethyl acetate: Methanol: Ammonia (7.0:1.4:0.7 v/v/v) as the mobile phase. Densitometric analysis of was performed at 231nm in concentration range 100-1200 ng/spot with range of recovery  99.91± 0.91%  for MTKT and  50-600 ng/spot with range of recovery 99.28± 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 method due to its effective separation of the drugs from its degradation products.

Keywords

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

Cite This Article

Nilam, P., Shirish, P., Dhara, P. (2012). Development and Validation of a Stability-indicating HPTLC Method for Analysis of Antiasthmatic Drugs, International Journal for Pharmaceutical Research Scholars (IJPRS), 1(2), 8-16.