Stability-indicating RP-HPLC Method for the Simultaneous Determination of Sitagliptin and Simvastatin in Tablets
A new stability-indicating high-performance liquid chromatographic method for simultaneous analysis of sitagliptin and simvastatin in pharmaceutical dosage form was developed and validated. The mobile phase consisted of methanol and water (70:30, v/v) with 0.2 % of n-heptane sulfonic acid adjusted t...
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Veröffentlicht in: | Indian journal of pharmaceutical sciences 2014-09, Vol.76 (5), p.407-414 |
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description | A new stability-indicating high-performance liquid chromatographic method for simultaneous analysis of sitagliptin and simvastatin in pharmaceutical dosage form was developed and validated. The mobile phase consisted of methanol and water (70:30, v/v) with 0.2 % of n-heptane sulfonic acid adjusted to pH 3.0 with ortho phosphoric acid was used. Retentions of sitagliptin and simvastatin were 4.3 min and 30.4 min, respectively with a flow rate of 1 ml/min on C8 (Qualisil BDS, 250×4.6 mm, 5 μ). Eluents were detected at 253 nm using photodiode diode array detector. The linear regression analysis data for the linearity plot showed correlation coefficient values of 0.9998 and 0.9993 for sitagliptin and simvastatin, with respective concentration ranges of 20-150 μg/ml and 8-60 μg/ml. The relative standard deviation for inter-day precision was lower than 2.0%. The assay of sitagliptin and simvastatin was determined in tablet dosage form was found to be within limits. Both drugs were subjected to a variety of stress conditions such as acidic, basic, oxidation, photolytic, neutral and thermal stress in order to achieve adequate degradation. Results revealed that considerable degradation was found in all stress conditions except oxidative degradations. The method has proven specificity for stability indicating assay method. |
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The mobile phase consisted of methanol and water (70:30, v/v) with 0.2 % of n-heptane sulfonic acid adjusted to pH 3.0 with ortho phosphoric acid was used. Retentions of sitagliptin and simvastatin were 4.3 min and 30.4 min, respectively with a flow rate of 1 ml/min on C8 (Qualisil BDS, 250×4.6 mm, 5 μ). Eluents were detected at 253 nm using photodiode diode array detector. The linear regression analysis data for the linearity plot showed correlation coefficient values of 0.9998 and 0.9993 for sitagliptin and simvastatin, with respective concentration ranges of 20-150 μg/ml and 8-60 μg/ml. The relative standard deviation for inter-day precision was lower than 2.0%. The assay of sitagliptin and simvastatin was determined in tablet dosage form was found to be within limits. Both drugs were subjected to a variety of stress conditions such as acidic, basic, oxidation, photolytic, neutral and thermal stress in order to achieve adequate degradation. Results revealed that considerable degradation was found in all stress conditions except oxidative degradations. The method has proven specificity for stability indicating assay method.</description><identifier>ISSN: 0250-474X</identifier><identifier>EISSN: 1998-3743</identifier><identifier>PMID: 25425754</identifier><language>eng</language><publisher>India: Medknow Publications and Media Pvt. Ltd</publisher><subject>Accuracy ; Acids ; Calibration ; Chemical properties ; Chromatography ; Composition ; Drug dosages ; High performance liquid chromatography ; Identification and classification ; Ions ; Methods ; Pharmaceuticals ; Regression analysis ; Research Paper ; Retention ; Simvastatin ; Sitagliptin ; Studies ; Tablets (Medicine)</subject><ispartof>Indian journal of pharmaceutical sciences, 2014-09, Vol.76 (5), p.407-414</ispartof><rights>COPYRIGHT 2014 Medknow Publications and Media Pvt. Ltd.</rights><rights>Copyright Medknow Publications & Media Pvt Ltd Sep-Oct 2014</rights><rights>Copyright: © Indian Journal of Pharmaceutical Sciences 2014</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4243257/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4243257/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25425754$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ramalingam, P</creatorcontrib><creatorcontrib>Bhaskar, V Udaya</creatorcontrib><creatorcontrib>Reddy, Y Padmanabha</creatorcontrib><creatorcontrib>Kumar, K Vinod</creatorcontrib><title>Stability-indicating RP-HPLC Method for the Simultaneous Determination of Sitagliptin and Simvastatin in Tablets</title><title>Indian journal of pharmaceutical sciences</title><addtitle>Indian J Pharm Sci</addtitle><description>A new stability-indicating high-performance liquid chromatographic method for simultaneous analysis of sitagliptin and simvastatin in pharmaceutical dosage form was developed and validated. The mobile phase consisted of methanol and water (70:30, v/v) with 0.2 % of n-heptane sulfonic acid adjusted to pH 3.0 with ortho phosphoric acid was used. Retentions of sitagliptin and simvastatin were 4.3 min and 30.4 min, respectively with a flow rate of 1 ml/min on C8 (Qualisil BDS, 250×4.6 mm, 5 μ). Eluents were detected at 253 nm using photodiode diode array detector. The linear regression analysis data for the linearity plot showed correlation coefficient values of 0.9998 and 0.9993 for sitagliptin and simvastatin, with respective concentration ranges of 20-150 μg/ml and 8-60 μg/ml. The relative standard deviation for inter-day precision was lower than 2.0%. The assay of sitagliptin and simvastatin was determined in tablet dosage form was found to be within limits. Both drugs were subjected to a variety of stress conditions such as acidic, basic, oxidation, photolytic, neutral and thermal stress in order to achieve adequate degradation. Results revealed that considerable degradation was found in all stress conditions except oxidative degradations. The method has proven specificity for stability indicating assay method.</description><subject>Accuracy</subject><subject>Acids</subject><subject>Calibration</subject><subject>Chemical properties</subject><subject>Chromatography</subject><subject>Composition</subject><subject>Drug dosages</subject><subject>High performance liquid chromatography</subject><subject>Identification and classification</subject><subject>Ions</subject><subject>Methods</subject><subject>Pharmaceuticals</subject><subject>Regression analysis</subject><subject>Research Paper</subject><subject>Retention</subject><subject>Simvastatin</subject><subject>Sitagliptin</subject><subject>Studies</subject><subject>Tablets (Medicine)</subject><issn>0250-474X</issn><issn>1998-3743</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><recordid>eNptkV1rFDEUhodSsWv1L0jAm96M5HMzcyOUrVphxWIreBfO5GM2JZNsZzIL_fdmaLVWJIFAzpMneXOOqhVp26ZmkrPjaoWpwDWX_OdJ9WqabjFmLWXyZXVCBadCCr6q9tcZOh98vq99NF5D9rFH36_qy6vtBn21eZcMcmlEeWfRtR_mkCHaNE_owmY7Dj6WEymi5Eo1Qx_8vhgQRLPQB5jyYkRl3kAXbJ5eVy8chMm-eVxPqx-fPt5sLuvtt89fNufbumdrkuumbQR30nVACda6a4xw2hneGtdZq7F2awolmgRNcCvAGNJxqptOGLC4Yey0-vDg3c_dYI22MY8Q1H70A4z3KoFXzyvR71SfDopTzsrnFMHZo2BMd7Odshr8pG0ID_kVWTMpJFljUtB3_6C3aR5jiVcoIltRXkifqB6CVT66VO7Vi1SdL41pFmOh3v-HKsPYwesUrfNl_9mBt38H_ZPwd4_ZL78fpUo</recordid><startdate>20140901</startdate><enddate>20140901</enddate><creator>Ramalingam, P</creator><creator>Bhaskar, V Udaya</creator><creator>Reddy, Y Padmanabha</creator><creator>Kumar, K Vinod</creator><general>Medknow Publications and Media Pvt. 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The mobile phase consisted of methanol and water (70:30, v/v) with 0.2 % of n-heptane sulfonic acid adjusted to pH 3.0 with ortho phosphoric acid was used. Retentions of sitagliptin and simvastatin were 4.3 min and 30.4 min, respectively with a flow rate of 1 ml/min on C8 (Qualisil BDS, 250×4.6 mm, 5 μ). Eluents were detected at 253 nm using photodiode diode array detector. The linear regression analysis data for the linearity plot showed correlation coefficient values of 0.9998 and 0.9993 for sitagliptin and simvastatin, with respective concentration ranges of 20-150 μg/ml and 8-60 μg/ml. The relative standard deviation for inter-day precision was lower than 2.0%. The assay of sitagliptin and simvastatin was determined in tablet dosage form was found to be within limits. Both drugs were subjected to a variety of stress conditions such as acidic, basic, oxidation, photolytic, neutral and thermal stress in order to achieve adequate degradation. Results revealed that considerable degradation was found in all stress conditions except oxidative degradations. The method has proven specificity for stability indicating assay method.</abstract><cop>India</cop><pub>Medknow Publications and Media Pvt. Ltd</pub><pmid>25425754</pmid><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Accuracy Acids Calibration Chemical properties Chromatography Composition Drug dosages High performance liquid chromatography Identification and classification Ions Methods Pharmaceuticals Regression analysis Research Paper Retention Simvastatin Sitagliptin Studies Tablets (Medicine) |
title | Stability-indicating RP-HPLC Method for the Simultaneous Determination of Sitagliptin and Simvastatin in Tablets |
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