Comparative Pharmacopoeial Analysis Of Three Brands Of Lidocaine 2°/O Injection Available In Uganda Pharmacies

ABSTRACT

Background: Lidocaine, is an important anesthetic and anti-arrhythmic drug, widely used in medicine,

at the same time a danger. The impurity 2, 6-xylidine is the starting material for its manufacture,

degradation product of lidocaine on storage and metabolite when administered. This study seeks to

identify 3 brands of lidocaine in Uganda Pharmacies, assess level of impurity and drug content by a

comparative pharmacopoeial chemical analysis.

Aim: To do a comparative pharmacopoeial analysis of the selected brands of Lidocaine 2% injection in

the volumes of 20ml that are within the shelf life of the drug and must be on the NDA approved list of

Drugs in Uganda.

Methods: Sample of each brand of Lidocaine was reacted and with 2ml of 10% cobalt II Chloride to

form a greenish blue precipitate. Secondly, the melting point of a salt formed with picric acid was

determine by capillary method. The colour intensity produced when samples reacted with 1% Pdimethyl

amino benzaldehyde was compared with the standard 400pp 2, 6-DMA solution in 10 mi. A

non-aqueous titration was performed with 5ml extract of each sample using crystal violet as indicator

and 0.02M perchloric acid as titrant. Each ml of0.02M HCL04 = 5.776mg of Lidocaine (BP, 2009).

Results: All brands were identified to be lidocaine, with levels of2, 6-Dimethyl aniline less than 400ppm

and drug concentration within the range 95 to 105% (BP, 2009). Conclusion: All brands of lidocaine complied with the pharmacopoeial standards.