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A Validated RP-HPLC Stability Method for the Estimation of Chlorthalidone and Its Process-Related Impurities in an API and Tablet Formulation
المؤلفون المشاركون
Kharat, Chaitali
Shirsat, Vaishali A.
Kodgule, Yogita M.
Kodgule, Mandar
المصدر
International Journal of Analytical Chemistry
العدد
المجلد 2020، العدد 2020 (31 ديسمبر/كانون الأول 2020)، ص ص. 1-11، 11ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2020-04-10
دولة النشر
مصر
عدد الصفحات
11
التخصصات الرئيسية
الملخص EN
Low-dose thiazide and thiazide-like diuretics are widely used as first-line therapy for hypertension.
Chlorthalidone, a monosulfamyl diuretic, is frequently prescribed in cases of hypertension and congestive heart failure.
In this research paper, an improved reverse-phase HPLC method was developed for the simultaneous identification and quantitation of pharmacopoeia-listed and in-house process- and degradation-related impurities of chlorthalidone in bulk drug and formulations.
Chromatographic separation was carried out on a C8 column (250 × 4.6 mm; ‘5 μm particle size) at a flow rate of 1.4 mL/min with a 220 nm detection wavelength.
Mobile phase A consisted of buffer solution (diammonium hydrogen orthophosphate (10 mM, pH 5.5)) and methanol at a 65 : 35 ratio (v/v), and mobile phase B consisted of buffer solution and methanol at a 50 : 50 ratio (v/v).
The API and formulation were subjected to stress conditions such as acid, alkali, oxidation, thermal, and photolytic conditions.
Validation studies for the in-house process impurities were performed for specificity, limit of detection (LOD), limit of quantitation (LOQ), linearity, precision, accuracy, and robustness.
Thus, an improved RP-HPLC method capable of good separation of all known and unknown impurities with acceptable resolution and tailing factor was developed.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Kharat, Chaitali& Shirsat, Vaishali A.& Kodgule, Yogita M.& Kodgule, Mandar. 2020. A Validated RP-HPLC Stability Method for the Estimation of Chlorthalidone and Its Process-Related Impurities in an API and Tablet Formulation. International Journal of Analytical Chemistry،Vol. 2020, no. 2020, pp.1-11.
https://search.emarefa.net/detail/BIM-1167622
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Kharat, Chaitali…[et al.]. A Validated RP-HPLC Stability Method for the Estimation of Chlorthalidone and Its Process-Related Impurities in an API and Tablet Formulation. International Journal of Analytical Chemistry No. 2020 (2020), pp.1-11.
https://search.emarefa.net/detail/BIM-1167622
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Kharat, Chaitali& Shirsat, Vaishali A.& Kodgule, Yogita M.& Kodgule, Mandar. A Validated RP-HPLC Stability Method for the Estimation of Chlorthalidone and Its Process-Related Impurities in an API and Tablet Formulation. International Journal of Analytical Chemistry. 2020. Vol. 2020, no. 2020, pp.1-11.
https://search.emarefa.net/detail/BIM-1167622
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1167622
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
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