Title:Development and Validation of a Stability-Indicating HPLC Method for the Assay of Carvedilol in Pure and Tablet Dosage Forms
VOLUME: 14 ISSUE: 2
Author(s):Sofia Ahmed, Anam Khan, Muhammad Ali Sheraz*, Rehana Bano and Iqbal Ahmad
Affiliation:Baqai Institute of Pharmaceutical Sciences, Baqai Medical University, 51, Deh Tor, Toll Plaza, Super Highway, Gadap Road, Karachi-74600, Baqai Institute of Pharmaceutical Sciences, Baqai Medical University, 51, Deh Tor, Toll Plaza, Super Highway, Gadap Road, Karachi-74600, Baqai Institute of Pharmaceutical Sciences, Baqai Medical University, 51, Deh Tor, Toll Plaza, Super Highway, Gadap Road, Karachi-74600, Getz Pharma (Pvt.) Limited, Korangi Industrial Area, Karachi-74900, Baqai Institute of Pharmaceutical Sciences, Baqai Medical University, 51, Deh Tor, Toll Plaza, Super Highway, Gadap Road, Karachi-74600
Keywords:Carvedilol, HPLC stability-indicating method, tablets, USP method, validation, forced degradation.
Abstract:Background: Carvedilol (CD) is a β-blocker drug that is used in the treatment of hypertension,
coronary diseases, etc. The official methods for the assay of CD in British Pharmacopoeia (BP)
and United States Pharmacopeia (USP) include potentiometric titration and HPLC analysis, respectively.
There are two different methods reported in the USP; one is for the pure CD and the other is for
its tablet dosage forms. Both methods are time consuming, require stringent preparation and have specific
requirements such as temperature.
Objective: The present study involves the development and validation of a simple, rapid and economical,
stability-indicating RP-HPLC method for the assay of CD in pure and tablet dosage forms.
Method: A mobile phase of acetonitrile and water in a ratio of 60:40, v/v, has been used for the assay of
CD at pH 2.5 giving the retention time (tR) of around 3 min. The method has been validated according
to the guidelines of International Council for Harmonization (ICH) for parameters such as linearity,
range, accuracy, precision, sensitivity, robustness and specificity.
Results: The results indicate that the method is linear in the range of 25-150% (6.25-37.50 µg/ml), highly
accurate (100.1%), precise (<1%), robust (<1.5%) and statistically comparable to the official USP methods.
Conclusion: The stress degradation studies yielded a number of degradation products with varying tR
values, all different from the principle peak of CD thus indicating that the method is highly specific and
reliable for the assay of CD.
