Dissolution Method Development and Validation for Lercanidipine Hydrochloride Tablets

Abstract

Lercanidipine hydrochloride (HCl) is L-type calcium channel blocker widely used in the management of hypertension. According to the BCS classification system, it is classified under BCS class II drugs, showing low solubility and high permeability. The dissolution profile and thus the in vivo performance of this class of drugs widely depend on their solubility and hence their behaviour in dissolution medium. Lercanidipine HCl is not official in any pharmacopeia, so no official dissolution method is available. The present work is mainly focussed on development and validation of a dissolution test that can be used as a quality control test for lercanidipine HCl tablets and formulations. Saturation solubility and sink conditions that can be achieved in different media suggested that 0.1 N HCl, acetate buffer pH 4.5, and phosphate buffer pH 6.8 can be used as a dissolution medium. Dissolution tests of lercanidipine HCl tablets were carried out in these different media at different rotation speeds using a USP type II (paddle) apparatus. The most suitable dissolution conditions were 0.1 N HCl pH 1.2 (900 mL at 37 ± 0.5 °C) as a dissolution medium and a paddle apparatus at 100 rpm for 60 min. The analysis of released lercanidipine HCl was done by ultraviolet spectrophotometry. The developed method was validated according to ICH guidelines. This method showed linearity with an r 2 value of 0.999 within the concentration range of 2-20 µg/mL. The method was found to be accurate with recoveries ranging from 98.50% to 103.72%. The interday and intraday precision was below RSD 2%. The developed method can effectively be used for quality control evaluation of lercanidipine HCl tablets.

Production and characterization of an acido-thermophilic, organic solvent stable cellulase from Bacillus sonorensis HSC7 by conversion of lignocellulosic wastes

“…In addition, the optimum CMC concentration for enzyme production was achieved at 1%. Similar results were obtained from B. thuringiensis [20] While Achromobacter xylosoxidans BSS4 and Paenibacillus barcinonensis MG7 showed maximum cellulase activity at 0.5 and 2% concentration of CMC, respectively [21], [22].…”

Assessment of the pharmaceutical equivalence and in vitro dissolution studies of amlodipine tablets marketed in Northern Nigeria

“…The Dissolution of a solid dosage form is affected by the type and ratio of excipients, processing factors (methods of granulation and the compression force applied [8]. An in vitro dissolution test helps in formulation development, investigations for post-approval changes, quality control and post marketing surveillance [9]. Drug dissolution, a key factor in the success of therapeutic outcome of drug product, is a rate kinetic process that deals with how long it takes a solute to form a saturated solution.…”

Improvement of cellulose degradation by cloning of endo-β-1, 3-1, 4 glucanase (bgls) gene from Bacillus subtilis BTN7A strain

“…Maximum bgls production was obtained when using CMC (Table 2) this result confirmed the recently reported that Bacillus sp. produced maximum cellulases production in the presence of CMC as a carbon source [3], [21], [14], [23]. This finding indicates the positive regulation effect of CMC in cellulases gene expression in Bacillus .…”