Development of Potentiometric Method for In Situ Testing of Terbinafine HCl Dissolution Behavior Using Liquid Inner Contact Ion-Selective Electrode Membrane

Abstract

A novel potentiometric method for in-situ testing of terbinafine HCl dissolution behavior using novel liquid inner contact ionselective electrode membrane was developed. Terbinafine HCl is slightly soluble in water so, the use of ion-selective electrode for its determination is challenge. The sensor was polyvinyl chloride matrix membrane electrode in which sodium tetraphenylborate was used as cation exchanger and bis (2-ethyl hexyl) sebacate as plasticizer. The ion pair was formed by soaking membrane in drug solution. Linear response of terbinafine HCl was found in the dynamic range of 10 −6 to 10 −2 mol L −1 . Dissolution test was performed according to FDA regulations using paddle-(USP type 2). So, the proposed ion selective electrode membrane was successfully used as a benchtop in-situ monitor to study the dissolution behavior of terbinafine HCl tablets without need of sample pretreatment or complicated withdrawal steps. Also, the proposed sensor was successfully used for terbinafine HCl determination in dosage forms including spray formulation which contains alcohol percentage as solvent and urine with good recovery.

Ion exchanger‐based electrodes for determination of highly lipophilic physiologically active amines: Peculiarities of functioning and ways for improving analytical characteristics

“…It should be noted that the operating pH ranges given in [24,25] do not agree with the data on the solubility of the molecular form of terbinafine in water, which is 5.22 μM [27]. The pKa values of terbinafine given in the literature are characterized by a large scatter (from 7.05 to 8.94) [27][28][29], however, even with the maximum of the given values, the solubility of terbinafine at pH = 9 should not exceed 5×10 À 6 M. Further, according to [15] and [29], the potential of terbinafine-SE remains constant in the pH ranges 3-6 and 1-3, respectively, after which a sharp decrease in the potential occurs. The data presented in [29] are consistent with those obtained by us and seem to be the most reliable, although the given explanation of the drop in potential due to a decrease in the solubility of terbinafine at pH > 3, is not consistent with the rather high basicity of terbinafine.…”

Widening the applications of the Just-Dip-It approach: a solid contact screen-printed ion-selective electrode for the real-time assessment of pharmaceutical dissolution testing in comparison to off-line HPLC analysis

“… 19 Although the traditional LC-ISE has an inner filling solution that may be subjected to evaporation in the case of immersion in analyte solutions at high temperatures, it showed good performance for tracking the API release from their dosage forms. 20,21 SC-SP-ISE can provide better performance for the real-time tracking of dissolution testing.…”

Nanoparticle-Enhanced Potentiometric Ion-Selective Electrodes for Therapeutic Drug Monitoring of Linezolid

“…Moreover, ISEs require minimal or no sample pretreatment which makes them an ideal choice for routine analysis since they do not require a highly skilled analyst to operate. 30 This eco-friendly technique paved the way toward a greener analytical chemistry tools making it superior over chromatographic and electrophoretic techniques in biomedical analysis, [31][32][33] in dissolution profile 34 and as stability indicating methods. 35 Increasing sensitivity and selectivity of the fabricated sensors has always been the main target for analysts.…”