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Acta Biomedica Scientia

Volume 6, Issue 3, 2019
Mcmed International
Acta Biomedica Scientia
Issn
2348 - 215X (Print), 2348 - 2168 (Online)
Frequency
bi-annual
Email
editorabs@mcmed.us
Journal Home page
http://mcmed.us/journal/abs
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Abstract
Title
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ERGOTAMINE TARTRATE AND CAFFEINE IN BULK AND PHARMACEUTICAL DOSAGE FORMS
Author
Pavan Kumar T, Deepthi P
Email
pavankumarthati112@gmail.com
keyword
Agilent C18, Ergotamine tartrate and Caffeine, RP-HPLC
Abstract
A new method was established for simultaneous estimation of Ergotamine tartrate and Caffeine by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Ergotamine tartrate and Caffeine by using Agilent C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer ph4.0 : ACN (30:70%v/v), detection wave length was 254nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2.The retention times were found to be 2.507 mins and 3.233 mins. The % purity of Ergotamine tartrate and Caffeine was found to be 100.3% and 101.1% respectively. The system suitability parameters for Ergotamine tartrate and Caffeine such as theoretical plates and tailing factor were found to be 1.3, 5824.4 and 1.2, 2936.0 the resolution was found to be 9.4.The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Ergotamine tartrate and Caffeine was found in concentration range of 20?g- 100?g and 20?g-100?g and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 102.5% and 101.0%, %RSD for repeatability was 0.6 and 0.5, % RSD for intermediate precision was 0.7 and 0.6 respectively. The precision study was precise, robust, and repeatable. LOD value was 3.1 and 3.02, and LOQ value was 10.1 and 10 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Ergotamine tartrate and Caffeine in API and Pharmaceutical dosage form
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