Akshita A Agrawal, Jagdish K Sahu, Shilpa Dawre, Abhishek Kanugo
{"title":"通过开发和验证稳定指示型 RP-HPLC 方法测定散装和药物剂型中的奥美沙坦。","authors":"Akshita A Agrawal, Jagdish K Sahu, Shilpa Dawre, Abhishek Kanugo","doi":"10.2174/2949681016666230224153822","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Angiotensin II type 1 (AT 1) receptor antagonist (angiotensin receptor\nblocker (ARB) called Olmesartan medoxomil (OLM) prevents angiotensin II from acting on the\nrenin-angiotensin-aldosterone pathway, which is a crucial factor in the development of hypertension.\nOLM is reported to rapidly hydrolyze into its active metabolite, Olmesartan, in plasma after oral\ntreatment.</p><p><strong>Objective: </strong>The objective of the ongoing study was to develop an easy-to-use, precise, and reliable\nRP-HPLC method for the determination of Olmesartan in bulk as well as pharmaceutical dosage\nforms.</p><p><strong>Methods: </strong>The stability indicating HPLC method for assay includes the use of Kromasil 100-5-C8\n(100 mm × 4.6 mm) column, UV detector 265 nm, and mobile phase composition was a mixture of\nAcetonitrile: water (70:30) and flow rate of 1.0 mL/min. ICH guidelines were followed in the\nmethod's validation. To assess the method's specificity and stability in showing characteristics, stress\ndegradation studies were carried out. The working standard solution of Olmesartan was exposed to\n0.1 N HCl at room temperature, 0.1 N NaOH at room temperature, 30 percent hydrogen peroxide\nby volume, and UV radiation in order to conduct a degradation study.</p><p><strong>Results: </strong>The retention periods of the drug were found to be 1.36 and 1.47 min for standard and\nsample solutions, respectively. The degradation behaviour of drug under different conditions was\nstudied. The drug was found susceptible to acidic, alkaline and oxidative conditions while it was\nfound stable in photolytic condition. The developed stability-indicating RP-HPLC method for assay\nwas validated as per ICH Q2 guidelines and the validation parameters such as accuracy, precision\nand specificity were obtained within the accepted criteria.</p><p><strong>Conclusion: </strong>It may be concluded that this method is stability-indicating and specific and can\nsuccessfully be applied to analyze tablet dosage form containing Olmesartan.</p>","PeriodicalId":72844,"journal":{"name":"Drug metabolism and bioanalysis letters","volume":" ","pages":"65-72"},"PeriodicalIF":0.0000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Determination of Olmesartan in Bulk and Pharmaceutical Dosage Forms through the Development and Validation of Stability-indicating RP-HPLC Method.\",\"authors\":\"Akshita A Agrawal, Jagdish K Sahu, Shilpa Dawre, Abhishek Kanugo\",\"doi\":\"10.2174/2949681016666230224153822\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Angiotensin II type 1 (AT 1) receptor antagonist (angiotensin receptor\\nblocker (ARB) called Olmesartan medoxomil (OLM) prevents angiotensin II from acting on the\\nrenin-angiotensin-aldosterone pathway, which is a crucial factor in the development of hypertension.\\nOLM is reported to rapidly hydrolyze into its active metabolite, Olmesartan, in plasma after oral\\ntreatment.</p><p><strong>Objective: </strong>The objective of the ongoing study was to develop an easy-to-use, precise, and reliable\\nRP-HPLC method for the determination of Olmesartan in bulk as well as pharmaceutical dosage\\nforms.</p><p><strong>Methods: </strong>The stability indicating HPLC method for assay includes the use of Kromasil 100-5-C8\\n(100 mm × 4.6 mm) column, UV detector 265 nm, and mobile phase composition was a mixture of\\nAcetonitrile: water (70:30) and flow rate of 1.0 mL/min. ICH guidelines were followed in the\\nmethod's validation. To assess the method's specificity and stability in showing characteristics, stress\\ndegradation studies were carried out. The working standard solution of Olmesartan was exposed to\\n0.1 N HCl at room temperature, 0.1 N NaOH at room temperature, 30 percent hydrogen peroxide\\nby volume, and UV radiation in order to conduct a degradation study.</p><p><strong>Results: </strong>The retention periods of the drug were found to be 1.36 and 1.47 min for standard and\\nsample solutions, respectively. The degradation behaviour of drug under different conditions was\\nstudied. The drug was found susceptible to acidic, alkaline and oxidative conditions while it was\\nfound stable in photolytic condition. 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引用次数: 0
摘要
背景：血管紧张素II 1型（AT 1）受体拮抗剂（血管紧张素受体阻滞剂[ARB]）奥美沙坦酯（OLM）可阻止血管紧张素II作用于肾素-血管紧张素-醛固酮途径，而肾素-血管紧张素-醛固酮途径是高血压发病的关键因素。据报道，口服治疗后，OLM 会在血浆中迅速水解为其活性代谢物奥美沙坦：正在进行的研究旨在开发一种易于使用、精确可靠的 RP-HPLC 方法，用于测定散装和药物剂型中的奥美沙坦：稳定性指示高效液相色谱法采用 Kromasil 100-5-C8 (100 mm × 4.6 mm) 色谱柱，紫外检测器为 265 nm，流动相为乙腈：水（70:30）混合液，流速为 1.0 mL/min。方法验证遵循 ICH 指南。为评估该方法的特异性和稳定性，进行了应力降解研究。将奥美沙坦工作标准溶液暴露于室温下的 0.1 N HCl、室温下的 0.1 N NaOH、体积分数为 30% 的过氧化氢和紫外线辐射中，进行降解研究：标准溶液和样品溶液的药物保留期分别为 1.36 分钟和 1.47 分钟。研究了药物在不同条件下的降解行为。发现该药物易受酸性、碱性和氧化条件的影响，而在光解条件下则比较稳定。根据 ICH Q2 指南对所开发的稳定性指示 RP-HPLC 方法进行了验证，验证参数如准确度、精密度和特异性均符合公认标准：结论：该方法具有稳定性指示和特异性，可成功应用于含奥美沙坦片剂的分析。
Determination of Olmesartan in Bulk and Pharmaceutical Dosage Forms through the Development and Validation of Stability-indicating RP-HPLC Method.
Background: Angiotensin II type 1 (AT 1) receptor antagonist (angiotensin receptor
blocker (ARB) called Olmesartan medoxomil (OLM) prevents angiotensin II from acting on the
renin-angiotensin-aldosterone pathway, which is a crucial factor in the development of hypertension.
OLM is reported to rapidly hydrolyze into its active metabolite, Olmesartan, in plasma after oral
treatment.
Objective: The objective of the ongoing study was to develop an easy-to-use, precise, and reliable
RP-HPLC method for the determination of Olmesartan in bulk as well as pharmaceutical dosage
forms.
Methods: The stability indicating HPLC method for assay includes the use of Kromasil 100-5-C8
(100 mm × 4.6 mm) column, UV detector 265 nm, and mobile phase composition was a mixture of
Acetonitrile: water (70:30) and flow rate of 1.0 mL/min. ICH guidelines were followed in the
method's validation. To assess the method's specificity and stability in showing characteristics, stress
degradation studies were carried out. The working standard solution of Olmesartan was exposed to
0.1 N HCl at room temperature, 0.1 N NaOH at room temperature, 30 percent hydrogen peroxide
by volume, and UV radiation in order to conduct a degradation study.
Results: The retention periods of the drug were found to be 1.36 and 1.47 min for standard and
sample solutions, respectively. The degradation behaviour of drug under different conditions was
studied. The drug was found susceptible to acidic, alkaline and oxidative conditions while it was
found stable in photolytic condition. The developed stability-indicating RP-HPLC method for assay
was validated as per ICH Q2 guidelines and the validation parameters such as accuracy, precision
and specificity were obtained within the accepted criteria.
Conclusion: It may be concluded that this method is stability-indicating and specific and can
successfully be applied to analyze tablet dosage form containing Olmesartan.
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