Quantitation of Pregabalin by HPLC-UV Method using Ninhydrin Derivatization: Development and Validation

被引:3
|
作者
Mutalabisin, Fathiy [1 ]
Helaluddin, Abul Bashar Mohammed [1 ]
Sengupta, Pinaki [3 ]
Mohamed, Farahidah [1 ]
Chatterjee, Bappaditya [1 ,2 ]
机构
[1] Int Islamic Univ Malaysia, Kulliyyah Pharm, Kuantan, Malaysia
[2] SVKMs NMIMS, Shobhaben Pratapbhai Patel Sch Pharm & Technol Ma, Mumbai, Maharashtra, India
[3] Natl Inst Pharmaceut Educ & Res NIPER, Ahmadabad, Gujarat, India
关键词
Pregabalin; ninhydrin; precolumn derivatization; HPLC; UV detection; analytical method development; analytical method validation; PRECOLUMN DERIVATIZATION; GABAPENTIN;
D O I
10.2174/1573412916666191114120213
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Introduction: A simple and reliable high performance liquid chromatographic method has been developed for the quantitative determination of pregabalin in bulk and dosage form. Pregabalin, a gamma amino butyric acid analogue, has negligible sensitivity to UV or fluorescence detection. Hence, it has been derivatized by ninhydrin to form a chromophoric complex that could be quantified by UV detection. Materials and Methods: The concentration of ninhydrin was set to 5 mg/ml and a phosphate buffer solution (pH 7.4) was used as a solvent for the reaction. The resultant complex was separated by HPLC and detected by a UV detector at 569nm wavelength. Results: The developed method showed a linear response within 50 to 600 mu g/mL of pregabalin. The method was accurate with mean recovery values within 100 +/- 2%. The repeatability of the method was established by intra-day and inter-day precision study. Finally, a commercial pregabalin capsule was assayed by the developed HPLC method including ninhydrin derivatization. The result of the mean assay was found to be 100.37 +/- 2.94 %. Conclusion: This is the first time we are reporting pregabalin analysis using ninhydrin derivatization for HPLC analysis. Therefore, the developed method can be considered as a significant improvement in pregabalin quantitation and it can be easily applied for routine quality control tests of pregabalin.
引用
收藏
页码:165 / 171
页数:7
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