VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF NORTRIPTYLINE AND PREGABALIN IN BULK AND COMBINED DOSAGE FORMULATIONS
A simple and precise stability indicating RP-HPLC method was developed for simultaneous analysis of drug nortriptyline and pregabalin using BDS (250mm x 4.6 mm, 5μ) C18 column at 210 nm of UV detection. Perchloric acid (0.1%) and acetonitrile in the ratio of 55:45 was used as the mobile phase with a flow rate of 1.0 ml/min and linearity response was established over the concentration range of 5-30 μg/ml for nortriptyline and 37.5-225 μg/ml for pregabalin. The active pharmaceutical ingredients recovered for nortriptyline and pregabalin are in the range of 100.60-101.65% and 100.59-101.74% respectively. The method was validated and was found to be stability indicating and can be successfully utilized for the quantitative analysis of pharmaceutical tablet dosage formulations containing nortriptyline and pregabalin.
Main Authors: | , , |
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Format: | Digital revista |
Language: | English |
Published: |
Sociedad Chilena de Química
2017
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Online Access: | http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072017000200013 |
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Summary: | A simple and precise stability indicating RP-HPLC method was developed for simultaneous analysis of drug nortriptyline and pregabalin using BDS (250mm x 4.6 mm, 5μ) C18 column at 210 nm of UV detection. Perchloric acid (0.1%) and acetonitrile in the ratio of 55:45 was used as the mobile phase with a flow rate of 1.0 ml/min and linearity response was established over the concentration range of 5-30 μg/ml for nortriptyline and 37.5-225 μg/ml for pregabalin. The active pharmaceutical ingredients recovered for nortriptyline and pregabalin are in the range of 100.60-101.65% and 100.59-101.74% respectively. The method was validated and was found to be stability indicating and can be successfully utilized for the quantitative analysis of pharmaceutical tablet dosage formulations containing nortriptyline and pregabalin. |
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