University of Khartoum

Spectroscopic Methods for Analysis of Gabapentin and Mefenamic Acid in Their Pharmaceutical Formulations

Spectroscopic Methods for Analysis of Gabapentin and Mefenamic Acid in Their Pharmaceutical Formulations

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Title: Spectroscopic Methods for Analysis of Gabapentin and Mefenamic Acid in Their Pharmaceutical Formulations
Author: Mohamed, Tamador Omer Mahamoud
Abstract: In this study optimization and validation of spectrophotometric and spectrofluormetric methods for the determination of two pharmaceutical drugs containing amino group namely Gabapentin and Mefenamic acid in their pharmaceutical formulation were described. Two simple, accurate, precise, sensitive and rapid spectrophotometric (Method A) and spectrofluormetric (Method B) were developed and validated. Method (A) was based on derivatization of the amino group of GAB and MF with 7-Chloro-4-Nitrobenzoxadiazole NBD-Cl in alkaline medium at pH 10 forming colored products at 476 and 466 nm, respectively. Beer’s law was obeyed over the range 10 to 60 µg/mL for GAB and from 20 to 100 µg/mL for MF . The Limits of detection (LOD) for both were found to be 1.725 and 3.911 µg/mL and the limits of quantitation (LOQ) were found to be 5.227 and 11.85 µg/mL, respectively. Method (B) was based on the reaction of GAB with 7-Chloro-4-Nitrobenzoxadiazole NBD-Cl at pH 10.0, producing yellow-colored products measured excitation λex 480 and emission λem 549. The calibration curves were linear over concentrations ranging from 0.2 to 1.0 µg/mL. LOD was found to be 0.0079 µg/mL and LOQ was found to be 0.0241 µg/mL. For MF, method (B) was based on the forming inclusion complex between the drug and β- cyclodextrin. The product showed an excitation λex 305 nm, and emission λem 405 nm. Beer’s law was obeyed over the range 5 to 30 µg/mL. LOD was found to be 1.272 µg/mL, and LOQ was found to be 3.856 µg/mL. Different variables affecting these reactions were carefully studied and optimized. The two methods were validated with respect to accuracy, precision, linearity, sensitivity, LOD, and LOQ according to the International Conference of Harmonization (ICH) guidelines for validation of analytical procedure. The two proposed methods were applied successfully for determination of GAB and MF in their pharmaceutical formulation. The percentages were found to be in range of 103-104% and 98.6 - 99.6% for GAB and MF respectively. The two drugs did not need any complex sample preparation such as extraction step prior to the drug analysis.
URI: http://khartoumspace.uofk.edu/123456789/24519


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