{"title":"稳定性指示反相高效液相色谱法测定硫酸阿扎那韦散装和剂型的含量","authors":"Charushila H. Bhirud , Shivanand N. Hiremath","doi":"10.1016/j.dit.2013.05.008","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>The objective of the present work is to develop a simple, precise, accurate, validated stability indicating RP-HPLC method for the determination of Atazanavir sulphate in bulk and capsule dosage form.</p></div><div><h3>Method</h3><p>A validated stability indicating RP-HPLC method for the estimation of Atazanavir sulphate in capsule dosage form on Agilent TC C18 (2) 250 × 4.6 mm, 5 μ column using mobile phase composition of 0.02 M ammonium dihydrogen phosphate buffer:acetonitrile:methanol (30:25:45 v/v) and pH adjusted at 2.5 with <em>ortho</em>-phosphoric acid. Flow rate was maintained at 1 ml/min at an ambient temperature. Quantification was achieved with ultraviolet detection at 288 nm.</p></div><div><h3>Results</h3><p>The retention time obtained for Atazanavir sulphate was at 3.0 min. The result obtained with the detector response was found to be linear in the concentration range of 5–50 μg/ml. This method has been validated and shown to be specific, sensitive, precise, linear, accurate, rugged, robust and fast. Atazanavir sulphate was subjected to different accelerated stress conditions. The degradation products, when anywhere well resolved from the pure drug with significantly different retention time values.</p></div><div><h3>Conclusion</h3><p>It is concluded that this method can be applied for routine quality control of Atazanavir sulphate in capsule dosage forms as well as in bulk drug.</p></div>","PeriodicalId":11284,"journal":{"name":"Drug Invention Today","volume":"5 2","pages":"Pages 81-86"},"PeriodicalIF":0.0000,"publicationDate":"2013-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.dit.2013.05.008","citationCount":"8","resultStr":"{\"title\":\"Stability indicating RP-HPLC method for the determination of Atazanavir sulphate in bulk and dosage form\",\"authors\":\"Charushila H. Bhirud , Shivanand N. Hiremath\",\"doi\":\"10.1016/j.dit.2013.05.008\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>The objective of the present work is to develop a simple, precise, accurate, validated stability indicating RP-HPLC method for the determination of Atazanavir sulphate in bulk and capsule dosage form.</p></div><div><h3>Method</h3><p>A validated stability indicating RP-HPLC method for the estimation of Atazanavir sulphate in capsule dosage form on Agilent TC C18 (2) 250 × 4.6 mm, 5 μ column using mobile phase composition of 0.02 M ammonium dihydrogen phosphate buffer:acetonitrile:methanol (30:25:45 v/v) and pH adjusted at 2.5 with <em>ortho</em>-phosphoric acid. Flow rate was maintained at 1 ml/min at an ambient temperature. Quantification was achieved with ultraviolet detection at 288 nm.</p></div><div><h3>Results</h3><p>The retention time obtained for Atazanavir sulphate was at 3.0 min. The result obtained with the detector response was found to be linear in the concentration range of 5–50 μg/ml. This method has been validated and shown to be specific, sensitive, precise, linear, accurate, rugged, robust and fast. Atazanavir sulphate was subjected to different accelerated stress conditions. The degradation products, when anywhere well resolved from the pure drug with significantly different retention time values.</p></div><div><h3>Conclusion</h3><p>It is concluded that this method can be applied for routine quality control of Atazanavir sulphate in capsule dosage forms as well as in bulk drug.</p></div>\",\"PeriodicalId\":11284,\"journal\":{\"name\":\"Drug Invention Today\",\"volume\":\"5 2\",\"pages\":\"Pages 81-86\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2013-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1016/j.dit.2013.05.008\",\"citationCount\":\"8\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug Invention Today\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0975761913000343\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Invention Today","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0975761913000343","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Stability indicating RP-HPLC method for the determination of Atazanavir sulphate in bulk and dosage form
Objective
The objective of the present work is to develop a simple, precise, accurate, validated stability indicating RP-HPLC method for the determination of Atazanavir sulphate in bulk and capsule dosage form.
Method
A validated stability indicating RP-HPLC method for the estimation of Atazanavir sulphate in capsule dosage form on Agilent TC C18 (2) 250 × 4.6 mm, 5 μ column using mobile phase composition of 0.02 M ammonium dihydrogen phosphate buffer:acetonitrile:methanol (30:25:45 v/v) and pH adjusted at 2.5 with ortho-phosphoric acid. Flow rate was maintained at 1 ml/min at an ambient temperature. Quantification was achieved with ultraviolet detection at 288 nm.
Results
The retention time obtained for Atazanavir sulphate was at 3.0 min. The result obtained with the detector response was found to be linear in the concentration range of 5–50 μg/ml. This method has been validated and shown to be specific, sensitive, precise, linear, accurate, rugged, robust and fast. Atazanavir sulphate was subjected to different accelerated stress conditions. The degradation products, when anywhere well resolved from the pure drug with significantly different retention time values.
Conclusion
It is concluded that this method can be applied for routine quality control of Atazanavir sulphate in capsule dosage forms as well as in bulk drug.
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