Stability-Indicating HPLC Method for the Determination of Impurities in Meprobamate with Refractive Index Detection
The purpose of this study is to develop and validate a simple, sensitive, and robust high-performance liquid chromagraphic (HPLC) method for the determination of impurities ca. 2-methyl-2-propyl-1,3-propane diol (MP0) and 2-hydroxymethyl-2-methyl pentyl carbamate (MP1) in meprobamate (MEP) drug subs...
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| Veröffentlicht in: | Journal of chromatographic science 2010-03, Vol.48 (3), p.212-218 |
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| creator | Karthikeyan, K. Balaji, T.S. Shanmugasundaram, P. Pillai, K. Chandrasekara |
| description | The purpose of this study is to develop and validate a simple, sensitive, and robust high-performance liquid chromagraphic (HPLC) method for the determination of impurities ca. 2-methyl-2-propyl-1,3-propane diol (MP0) and 2-hydroxymethyl-2-methyl pentyl carbamate (MP1) in meprobamate (MEP) drug substance with refractive index (RI) detection. This method utilizes a Zorbax Eclipse XDB C18 HPLC column, a mobile phase of 80:20 (v/v) 10 mM KH2PO4,-acetonitrile, respectively. The stability-indicating capability of the method has been established by performing stress studies under acidic, basic, oxidation, light, humidity, and thermal conditions. The major degradation products of acid and base hydrolysis are identified as MP0 and MP1. The recovery data obtained for impurities are between 96.0–109.8%. The detection and quantitation limits of this method ranges from 0.009 to 0.017 mg/mL and 0.029 to 0.055 mg/mL, respectively. The relative standard deviation (RSD) for the area at QL is less than 6.1%. Good linearity (r2 > 0.99) and precision (RSD < 2.2%) have been obtained for MEP, MP0, and MP1. This method has been applied successfully to determine the content of impurities in MEP bulk drug. |
| doi_str_mv | 10.1093/chromsci/48.3.212 |
| format | Article |
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The detection and quantitation limits of this method ranges from 0.009 to 0.017 mg/mL and 0.029 to 0.055 mg/mL, respectively. The relative standard deviation (RSD) for the area at QL is less than 6.1%. Good linearity (r2 > 0.99) and precision (RSD < 2.2%) have been obtained for MEP, MP0, and MP1. This method has been applied successfully to determine the content of impurities in MEP bulk drug.</description><identifier>ISSN: 0021-9665</identifier><identifier>EISSN: 1945-239X</identifier><identifier>DOI: 10.1093/chromsci/48.3.212</identifier><identifier>PMID: 20223088</identifier><identifier>CODEN: JCHSBZ</identifier><language>eng</language><publisher>Niles, IL: Oxford University Press</publisher><subject>Analysis ; Biological and medical sciences ; Carbamates - analysis ; Chromatography, High Pressure Liquid - methods ; Drug Contamination ; General pharmacology ; Limit of Detection ; Medical sciences ; Meprobamate - chemistry ; Muscle Relaxants, Central - chemistry ; Pharmacology. 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Chandrasekara</creatorcontrib><title>Stability-Indicating HPLC Method for the Determination of Impurities in Meprobamate with Refractive Index Detection</title><title>Journal of chromatographic science</title><addtitle>Journal of Chromatographic Science</addtitle><addtitle>Journal of Chromatographic Science</addtitle><description>The purpose of this study is to develop and validate a simple, sensitive, and robust high-performance liquid chromagraphic (HPLC) method for the determination of impurities ca. 2-methyl-2-propyl-1,3-propane diol (MP0) and 2-hydroxymethyl-2-methyl pentyl carbamate (MP1) in meprobamate (MEP) drug substance with refractive index (RI) detection. This method utilizes a Zorbax Eclipse XDB C18 HPLC column, a mobile phase of 80:20 (v/v) 10 mM KH2PO4,-acetonitrile, respectively. The stability-indicating capability of the method has been established by performing stress studies under acidic, basic, oxidation, light, humidity, and thermal conditions. The major degradation products of acid and base hydrolysis are identified as MP0 and MP1. The recovery data obtained for impurities are between 96.0–109.8%. The detection and quantitation limits of this method ranges from 0.009 to 0.017 mg/mL and 0.029 to 0.055 mg/mL, respectively. The relative standard deviation (RSD) for the area at QL is less than 6.1%. Good linearity (r2 > 0.99) and precision (RSD < 2.2%) have been obtained for MEP, MP0, and MP1. This method has been applied successfully to determine the content of impurities in MEP bulk drug.</description><subject>Analysis</subject><subject>Biological and medical sciences</subject><subject>Carbamates - analysis</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Drug Contamination</subject><subject>General pharmacology</subject><subject>Limit of Detection</subject><subject>Medical sciences</subject><subject>Meprobamate - chemistry</subject><subject>Muscle Relaxants, Central - chemistry</subject><subject>Pharmacology. 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Chandrasekara</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c448t-ef384fda34a0203f425f4066e9af865c68b95ff284b2c3762e85ed5733eb0cd93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Analysis</topic><topic>Biological and medical sciences</topic><topic>Carbamates - analysis</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Drug Contamination</topic><topic>General pharmacology</topic><topic>Limit of Detection</topic><topic>Medical sciences</topic><topic>Meprobamate - chemistry</topic><topic>Muscle Relaxants, Central - chemistry</topic><topic>Pharmacology. 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Chandrasekara</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Stability-Indicating HPLC Method for the Determination of Impurities in Meprobamate with Refractive Index Detection</atitle><jtitle>Journal of chromatographic science</jtitle><stitle>Journal of Chromatographic Science</stitle><addtitle>Journal of Chromatographic Science</addtitle><date>2010-03-01</date><risdate>2010</risdate><volume>48</volume><issue>3</issue><spage>212</spage><epage>218</epage><pages>212-218</pages><issn>0021-9665</issn><eissn>1945-239X</eissn><coden>JCHSBZ</coden><abstract>The purpose of this study is to develop and validate a simple, sensitive, and robust high-performance liquid chromagraphic (HPLC) method for the determination of impurities ca. 2-methyl-2-propyl-1,3-propane diol (MP0) and 2-hydroxymethyl-2-methyl pentyl carbamate (MP1) in meprobamate (MEP) drug substance with refractive index (RI) detection. This method utilizes a Zorbax Eclipse XDB C18 HPLC column, a mobile phase of 80:20 (v/v) 10 mM KH2PO4,-acetonitrile, respectively. The stability-indicating capability of the method has been established by performing stress studies under acidic, basic, oxidation, light, humidity, and thermal conditions. The major degradation products of acid and base hydrolysis are identified as MP0 and MP1. The recovery data obtained for impurities are between 96.0–109.8%. The detection and quantitation limits of this method ranges from 0.009 to 0.017 mg/mL and 0.029 to 0.055 mg/mL, respectively. The relative standard deviation (RSD) for the area at QL is less than 6.1%. Good linearity (r2 > 0.99) and precision (RSD < 2.2%) have been obtained for MEP, MP0, and MP1. This method has been applied successfully to determine the content of impurities in MEP bulk drug.</abstract><cop>Niles, IL</cop><pub>Oxford University Press</pub><pmid>20223088</pmid><doi>10.1093/chromsci/48.3.212</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Analysis Biological and medical sciences Carbamates - analysis Chromatography, High Pressure Liquid - methods Drug Contamination General pharmacology Limit of Detection Medical sciences Meprobamate - chemistry Muscle Relaxants, Central - chemistry Pharmacology. Drug treatments Propylene Glycols - analysis Refractometry - methods |
| title | Stability-Indicating HPLC Method for the Determination of Impurities in Meprobamate with Refractive Index Detection |
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