Stability Indicating RP-HPLC Method Development and Validation for the determination of Pretomanid an anti-bacterial drug

A new simple, rapid, accurate and stability indicating RP-HPLC method have been developed and validated for estimation of Pretomanid is an anti-bacterial agent in pharmaceutical dosage form. The RP-HPLC analysis was performed by using Xtimate C18 column (250mm × 4.6mm; 5µm) with Methanol: Acetonitri...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Research journal of pharmacy and technology 2023-05, Vol.16 (5), p.2385-2392
Hauptverfasser: Srinivasa Rao, Peddi, Siva Rao, Tirukkovalluri, Sailaja, B. B. V., Suman, Pallapati, Jai Sri, G.
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page 2392
container_issue 5
container_start_page 2385
container_title Research journal of pharmacy and technology
container_volume 16
creator Srinivasa Rao, Peddi
Siva Rao, Tirukkovalluri
Sailaja, B. B. V.
Suman, Pallapati
Jai Sri, G.
description A new simple, rapid, accurate and stability indicating RP-HPLC method have been developed and validated for estimation of Pretomanid is an anti-bacterial agent in pharmaceutical dosage form. The RP-HPLC analysis was performed by using Xtimate C18 column (250mm × 4.6mm; 5µm) with Methanol: Acetonitrile: Ammonium phosphate buffer in the ratio of 55:40:05 (v/v/v) as mobile phase at a flow rate of 1.0mL/min and detected at 262nm wavelength. The calibration curve was linear over the concentration range from 10 to 40µg/mL and correlation coefficient was found to be 0.99. LOD and LOQ were estimated as 0.30µg/mL and 5.0µg/mL respectively. The % recovery was achieved from 98.67% to 99.96%. The method was applied for estimation in its pharmaceutical dosage form and assay result was 98.9% label claim. Proposed method showed excellent linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance criteria as per ICH guidelines. The Pretomanid drug was subjected to stress condition of Hydrolysis, Oxidation, Photolysis and Thermal degradation, Forced degradation study was carried out and the degradation products were well resolved from the pure Pretomanid drug. The proposed method was successfully applied for the estimation of Pretomanid drugs in commercial dosage form.
doi_str_mv 10.52711/0974-360X.2023.00393
format Article
fullrecord <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2832484888</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2832484888</sourcerecordid><originalsourceid>FETCH-LOGICAL-c144t-7c3cd5310ebb41ced7c5c182d3b1305457eeea49f70dfe220579d71bec51d6ad3</originalsourceid><addsrcrecordid>eNo9kNtqwzAMQMPYYGXrJwwMe07na-M8ju7SQsfKbuzNOLbSuiRx57iD_v3cdlQIJMSRBCfLbggeCVoQcofLgudsjL9HFFM2wpiV7CwbnMbnp57Iy2zY92ucYiwF5XKQ7d6jrlzj4g7NOuuMjq5bordFPl3MJ-gF4spb9AC_0PhNC11EurPoSzfOJtJ3qPYBxRUgCxFC67rj1NdoESD6VnfOppWU0eWVNglyukE2bJfX2UWtmx6G__Uq-3x6_JhM8_nr82xyP88N4TzmhWHGCkYwVBUnBmxhhCGSWlYRhgUXBQBoXtYFtjVQikVR2oJUYASxY23ZVXZ7vLsJ_mcLfVRrvw1deqmoZEkCl1ImShwpE3zfB6jVJrhWh50iWB1Eq71FtTeq9qLVQTT7A02XcjM</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2832484888</pqid></control><display><type>article</type><title>Stability Indicating RP-HPLC Method Development and Validation for the determination of Pretomanid an anti-bacterial drug</title><source>EZB-FREE-00999 freely available EZB journals</source><creator>Srinivasa Rao, Peddi ; Siva Rao, Tirukkovalluri ; Sailaja, B. B. V. ; Suman, Pallapati ; Jai Sri, G.</creator><creatorcontrib>Srinivasa Rao, Peddi ; Siva Rao, Tirukkovalluri ; Sailaja, B. B. V. ; Suman, Pallapati ; Jai Sri, G.</creatorcontrib><description>A new simple, rapid, accurate and stability indicating RP-HPLC method have been developed and validated for estimation of Pretomanid is an anti-bacterial agent in pharmaceutical dosage form. The RP-HPLC analysis was performed by using Xtimate C18 column (250mm × 4.6mm; 5µm) with Methanol: Acetonitrile: Ammonium phosphate buffer in the ratio of 55:40:05 (v/v/v) as mobile phase at a flow rate of 1.0mL/min and detected at 262nm wavelength. The calibration curve was linear over the concentration range from 10 to 40µg/mL and correlation coefficient was found to be 0.99. LOD and LOQ were estimated as 0.30µg/mL and 5.0µg/mL respectively. The % recovery was achieved from 98.67% to 99.96%. The method was applied for estimation in its pharmaceutical dosage form and assay result was 98.9% label claim. Proposed method showed excellent linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance criteria as per ICH guidelines. The Pretomanid drug was subjected to stress condition of Hydrolysis, Oxidation, Photolysis and Thermal degradation, Forced degradation study was carried out and the degradation products were well resolved from the pure Pretomanid drug. The proposed method was successfully applied for the estimation of Pretomanid drugs in commercial dosage form.</description><identifier>ISSN: 0974-3618</identifier><identifier>EISSN: 0974-360X</identifier><identifier>EISSN: 0974-306X</identifier><identifier>DOI: 10.52711/0974-360X.2023.00393</identifier><language>eng</language><publisher>Raipur: A&amp;V Publications</publisher><subject>Accuracy ; Calibration ; Drug dosages ; Ions ; Methods ; Pharmaceuticals ; Regression analysis ; Sensors ; Solvents ; Tuberculosis</subject><ispartof>Research journal of pharmacy and technology, 2023-05, Vol.16 (5), p.2385-2392</ispartof><rights>Copyright A&amp;V Publications May 2023</rights><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c144t-7c3cd5310ebb41ced7c5c182d3b1305457eeea49f70dfe220579d71bec51d6ad3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>Srinivasa Rao, Peddi</creatorcontrib><creatorcontrib>Siva Rao, Tirukkovalluri</creatorcontrib><creatorcontrib>Sailaja, B. B. V.</creatorcontrib><creatorcontrib>Suman, Pallapati</creatorcontrib><creatorcontrib>Jai Sri, G.</creatorcontrib><title>Stability Indicating RP-HPLC Method Development and Validation for the determination of Pretomanid an anti-bacterial drug</title><title>Research journal of pharmacy and technology</title><description>A new simple, rapid, accurate and stability indicating RP-HPLC method have been developed and validated for estimation of Pretomanid is an anti-bacterial agent in pharmaceutical dosage form. The RP-HPLC analysis was performed by using Xtimate C18 column (250mm × 4.6mm; 5µm) with Methanol: Acetonitrile: Ammonium phosphate buffer in the ratio of 55:40:05 (v/v/v) as mobile phase at a flow rate of 1.0mL/min and detected at 262nm wavelength. The calibration curve was linear over the concentration range from 10 to 40µg/mL and correlation coefficient was found to be 0.99. LOD and LOQ were estimated as 0.30µg/mL and 5.0µg/mL respectively. The % recovery was achieved from 98.67% to 99.96%. The method was applied for estimation in its pharmaceutical dosage form and assay result was 98.9% label claim. Proposed method showed excellent linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance criteria as per ICH guidelines. The Pretomanid drug was subjected to stress condition of Hydrolysis, Oxidation, Photolysis and Thermal degradation, Forced degradation study was carried out and the degradation products were well resolved from the pure Pretomanid drug. The proposed method was successfully applied for the estimation of Pretomanid drugs in commercial dosage form.</description><subject>Accuracy</subject><subject>Calibration</subject><subject>Drug dosages</subject><subject>Ions</subject><subject>Methods</subject><subject>Pharmaceuticals</subject><subject>Regression analysis</subject><subject>Sensors</subject><subject>Solvents</subject><subject>Tuberculosis</subject><issn>0974-3618</issn><issn>0974-360X</issn><issn>0974-306X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNo9kNtqwzAMQMPYYGXrJwwMe07na-M8ju7SQsfKbuzNOLbSuiRx57iD_v3cdlQIJMSRBCfLbggeCVoQcofLgudsjL9HFFM2wpiV7CwbnMbnp57Iy2zY92ucYiwF5XKQ7d6jrlzj4g7NOuuMjq5bordFPl3MJ-gF4spb9AC_0PhNC11EurPoSzfOJtJ3qPYBxRUgCxFC67rj1NdoESD6VnfOppWU0eWVNglyukE2bJfX2UWtmx6G__Uq-3x6_JhM8_nr82xyP88N4TzmhWHGCkYwVBUnBmxhhCGSWlYRhgUXBQBoXtYFtjVQikVR2oJUYASxY23ZVXZ7vLsJ_mcLfVRrvw1deqmoZEkCl1ImShwpE3zfB6jVJrhWh50iWB1Eq71FtTeq9qLVQTT7A02XcjM</recordid><startdate>20230501</startdate><enddate>20230501</enddate><creator>Srinivasa Rao, Peddi</creator><creator>Siva Rao, Tirukkovalluri</creator><creator>Sailaja, B. B. V.</creator><creator>Suman, Pallapati</creator><creator>Jai Sri, G.</creator><general>A&amp;V Publications</general><scope>AAYXX</scope><scope>CITATION</scope><scope>04Q</scope><scope>04S</scope><scope>04W</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20230501</creationdate><title>Stability Indicating RP-HPLC Method Development and Validation for the determination of Pretomanid an anti-bacterial drug</title><author>Srinivasa Rao, Peddi ; Siva Rao, Tirukkovalluri ; Sailaja, B. B. V. ; Suman, Pallapati ; Jai Sri, G.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c144t-7c3cd5310ebb41ced7c5c182d3b1305457eeea49f70dfe220579d71bec51d6ad3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Accuracy</topic><topic>Calibration</topic><topic>Drug dosages</topic><topic>Ions</topic><topic>Methods</topic><topic>Pharmaceuticals</topic><topic>Regression analysis</topic><topic>Sensors</topic><topic>Solvents</topic><topic>Tuberculosis</topic><toplevel>online_resources</toplevel><creatorcontrib>Srinivasa Rao, Peddi</creatorcontrib><creatorcontrib>Siva Rao, Tirukkovalluri</creatorcontrib><creatorcontrib>Sailaja, B. B. V.</creatorcontrib><creatorcontrib>Suman, Pallapati</creatorcontrib><creatorcontrib>Jai Sri, G.</creatorcontrib><collection>CrossRef</collection><collection>India Database</collection><collection>India Database: Business</collection><collection>India Database: Science &amp; Technology</collection><collection>ProQuest Central (Corporate)</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>Research journal of pharmacy and technology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Srinivasa Rao, Peddi</au><au>Siva Rao, Tirukkovalluri</au><au>Sailaja, B. B. V.</au><au>Suman, Pallapati</au><au>Jai Sri, G.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Stability Indicating RP-HPLC Method Development and Validation for the determination of Pretomanid an anti-bacterial drug</atitle><jtitle>Research journal of pharmacy and technology</jtitle><date>2023-05-01</date><risdate>2023</risdate><volume>16</volume><issue>5</issue><spage>2385</spage><epage>2392</epage><pages>2385-2392</pages><issn>0974-3618</issn><eissn>0974-360X</eissn><eissn>0974-306X</eissn><abstract>A new simple, rapid, accurate and stability indicating RP-HPLC method have been developed and validated for estimation of Pretomanid is an anti-bacterial agent in pharmaceutical dosage form. The RP-HPLC analysis was performed by using Xtimate C18 column (250mm × 4.6mm; 5µm) with Methanol: Acetonitrile: Ammonium phosphate buffer in the ratio of 55:40:05 (v/v/v) as mobile phase at a flow rate of 1.0mL/min and detected at 262nm wavelength. The calibration curve was linear over the concentration range from 10 to 40µg/mL and correlation coefficient was found to be 0.99. LOD and LOQ were estimated as 0.30µg/mL and 5.0µg/mL respectively. The % recovery was achieved from 98.67% to 99.96%. The method was applied for estimation in its pharmaceutical dosage form and assay result was 98.9% label claim. Proposed method showed excellent linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance criteria as per ICH guidelines. The Pretomanid drug was subjected to stress condition of Hydrolysis, Oxidation, Photolysis and Thermal degradation, Forced degradation study was carried out and the degradation products were well resolved from the pure Pretomanid drug. The proposed method was successfully applied for the estimation of Pretomanid drugs in commercial dosage form.</abstract><cop>Raipur</cop><pub>A&amp;V Publications</pub><doi>10.52711/0974-360X.2023.00393</doi><tpages>8</tpages></addata></record>
fulltext fulltext
identifier ISSN: 0974-3618
ispartof Research journal of pharmacy and technology, 2023-05, Vol.16 (5), p.2385-2392
issn 0974-3618
0974-360X
0974-306X
language eng
recordid cdi_proquest_journals_2832484888
source EZB-FREE-00999 freely available EZB journals
subjects Accuracy
Calibration
Drug dosages
Ions
Methods
Pharmaceuticals
Regression analysis
Sensors
Solvents
Tuberculosis
title Stability Indicating RP-HPLC Method Development and Validation for the determination of Pretomanid an anti-bacterial drug
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-30T03%3A26%3A06IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Stability%20Indicating%20RP-HPLC%20Method%20Development%20and%20Validation%20for%20the%20determination%20of%20Pretomanid%20an%20anti-bacterial%20drug&rft.jtitle=Research%20journal%20of%20pharmacy%20and%20technology&rft.au=Srinivasa%20Rao,%20Peddi&rft.date=2023-05-01&rft.volume=16&rft.issue=5&rft.spage=2385&rft.epage=2392&rft.pages=2385-2392&rft.issn=0974-3618&rft.eissn=0974-360X&rft_id=info:doi/10.52711/0974-360X.2023.00393&rft_dat=%3Cproquest_cross%3E2832484888%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2832484888&rft_id=info:pmid/&rfr_iscdi=true