ABSTRACT
A high performance thin layer chromatographic (HPTLC) method for the simultaneous quantification of lignocaine hydrochloride (LIG) and phenylephrine hydrochloride (PHE) is described. The mobile phase consisted of ethyl acetate-methanol ammonia (4:1:0.4 v/v/v). The densitometric determination of LIG and PHE was carried out at 262 nm and 291 nm, respectively. The calibration curves of LIG and PHE were linear in the range of 8-18 microg and 4-9 microg, respectively. The method was validated with respect to system precision, method precision, recoveries, intra-day and inter-day variation. The system was applied for the simultaneous determination of LIG and PHE from a new drug delivery system. The results indicate that the method is simple, specific, selective and reliable for simultaneous quantitative determination of LIG and PHE as bulk drug and from formulations.
Subject(s)
Chromatography, Thin Layer/methods , Lidocaine/analysis , Phenylephrine/analysis , Anesthetics, Local/administration & dosage , Anesthetics, Local/analysis , Anesthetics, Local/chemistry , Drug Delivery Systems , Drug Stability , Lidocaine/administration & dosage , Lidocaine/chemistry , Phenylephrine/administration & dosage , Quality Control , Reference Standards , Sympathomimetics/administration & dosage , Sympathomimetics/analysisABSTRACT
OBJECTIVE: The aim of this study was to determine the feasibility of a novel saliva-activated bioadhesive drug delivery system of lidocaine hydrochloride as a viable alternative to infiltration anesthesia in dentistry. STUDY DESIGN: The study was carried out in three stages. First, the drug delivery system (DDS) was subjectively evaluated for adherence to the gingival mucosa and peak effect of anesthesia. In the second stage, a comparative subjective and objective evaluation of the DDS with a marketed topical gel preparation was carried out. Finally an open label, nonblinded clinical trial was carried out using the exodontia model. A total of 49 extractions were attempted in 41 patients. The effect of the following variables was investigated in the study: (1) jaw (maxillary and mandibular), (2) overall mobility, (3) position-notation of tooth (1, 2, 3, 4 ...). The positive extractions were statistically analyzed by the t test comparison of means of two independent variables. RESULTS: Subjective evaluation revealed that the DDS adheres to the gingiva within a minute and produces peak effect in 15 minutes. Comparative study revealed that the DDS produces greater depth of anesthesia than the marketed topical gel. Of 49 extractions attempted with the DDS, 40 were successful, giving an efficacy of 81.63%. CONCLUSION: The novel saliva-activated bioadhesive drug delivery system of lidocaine hydrochloride exhibits potential as a feasible alternative to infiltration anesthesia in dentistry.