Abstract
BackgroundPregabalin, a γ-amino-n-butyric acid derivative, is an antiepileptic drug not yet official in any pharmacopeia and development of analytical procedures for this drug in bulk/formulation forms is a necessity. We herein, report a new, simple, extraction free, cost effective, sensitive and reproducible spectrophotometric method for the determination of the pregabalin.ResultsPregabalin, as a primary amine was reacted with ninhydrin in phosphate buffer pH 7.4 to form blue violet colored chromogen which could be measured spectrophotometrically at λmax 402.6 nm. The method was validated with respect to linearity, accuracy, precision and robustness. The method showed linearity in a wide concentration range of 50-1000 μg mL-1 with good correlation coefficient (0.992). The limits of assays detection was found to be 6.0 μg mL-1 and quantitation limit was 20.0 μg mL-1. The suggested method was applied to the determination of the drug in capsules. No interference could be observed from the additives in the capsules. The percentage recovery was found to be 100.43 ± 1.24.ConclusionThe developed method was successfully validated and applied to the determination of pregabalin in bulk and pharmaceutical formulations without any interference from common excipients. Hence, this method can be potentially useful for routine laboratory analysis of pregabalin.
Highlights
Pregabalin, a g-amino-n-butyric acid derivative, is an antiepileptic drug not yet official in any pharmacopeia and development of analytical procedures for this drug in bulk/formulation forms is a necessity
Several reports are there in literature for PRG determination based on chromatographic methods, i.e., gas chromatography-mass spectrophotometry (GC-MS), LC-MS-MS [3,4], HPLC [5,6,7] coupled with varying detection techniques like tandem mass spectrometry [8], fluorometry [9] and enantiospecific analysis [10]
The present study describes the evaluation of ninhydrin as a chromogenic reagent in the development of simple and a rapid spectrophotometric method for the determination PGB in its pharmaceutical dosage forms
Summary
Intercept Beer’s law limit (μg mL-1) Molar Absorptivity (L/mol-1/cm-1) Sandell’s sensitivity (μg/cm2/0.001 A.U). The percentage relative error was calculated as: Er % = [(found - added)/added] × 100 Recovery values from standard addition method followed for the bulk drug analysis ranged from 96.5 to 100.3% (Table 3). Interference Satisfactory values of the mean recovery values ± SD, RSD % and Er % in recovery studies in drug formulation (Table 4) revealed that there is no potential interference of the excipients listed by the manufacturer, i.e., talc, lactose monohydrate and maize starch This may be attributed to the dependence of the reaction in the proposed method on the presence of a primary aliphatic amino group in the drug molecule which is not present in any of these excepients. The recovered drug content was found to be 99.48%
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