Abstract
A new stability-indicating RP-HPLC method for the determination of metformin hydrochloride and nateglinide in tablets was developed. The chromatographic separation was performed on a C18 column employing 0.05 M potassium dihydrogen orthophosphate (pH 3)- acetonitrile (28:72 v/v) as the mobile phase with UV detection at 216 nm. Under the proposed chromatographic conditions, favourable retention parameters (tr, Rs) were obtained with good symmetry of the chromatographic peaks for the studied compounds. The validation studies performed as per ICH guidelines indicated high degree of accuracy, precision, with good degree of sensitivity and robustness of the proposed method. The drugs were subjected to acidic, alkaline hydrolysis, oxidation, wet heat, dry heat and photo degradation studies. The specificity of the method by forced degradation studies confirmed that the method could effectively separate the drugs in presence of their degradation products, hence it can be regarding as stability indicating.
Keywords: Metformin hydrochloride, Nateglinide, HPLC, Stability-indicating method
Current Pharmaceutical Analysis
Title:Stability-Indicating RP-HPLC Method for Determination of Metformin Hydrochloride and Natglinide in Bulk and Tablet Formulations
Volume: 8 Issue: 4
Author(s): Asha Thomas, Shrikrushna Patil, Rabindra Nanda, Lata Kothapalli and Avinash Deshpande
Affiliation:
Keywords: Metformin hydrochloride, Nateglinide, HPLC, Stability-indicating method
Abstract: A new stability-indicating RP-HPLC method for the determination of metformin hydrochloride and nateglinide in tablets was developed. The chromatographic separation was performed on a C18 column employing 0.05 M potassium dihydrogen orthophosphate (pH 3)- acetonitrile (28:72 v/v) as the mobile phase with UV detection at 216 nm. Under the proposed chromatographic conditions, favourable retention parameters (tr, Rs) were obtained with good symmetry of the chromatographic peaks for the studied compounds. The validation studies performed as per ICH guidelines indicated high degree of accuracy, precision, with good degree of sensitivity and robustness of the proposed method. The drugs were subjected to acidic, alkaline hydrolysis, oxidation, wet heat, dry heat and photo degradation studies. The specificity of the method by forced degradation studies confirmed that the method could effectively separate the drugs in presence of their degradation products, hence it can be regarding as stability indicating.
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Cite this article as:
Thomas Asha, Patil Shrikrushna, Nanda Rabindra, Kothapalli Lata and Deshpande Avinash, Stability-Indicating RP-HPLC Method for Determination of Metformin Hydrochloride and Natglinide in Bulk and Tablet Formulations, Current Pharmaceutical Analysis 2012; 8 (4) . https://dx.doi.org/10.2174/157341212803341636
DOI https://dx.doi.org/10.2174/157341212803341636 |
Print ISSN 1573-4129 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-676X |
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