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INTERNATIONAL JOURNAL OF SCIENTIFIC DEVELOPMENT AND RESEARCH International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016 open access , Peer-reviewed, and Refereed Journals, Impact factor 8.15 |
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| Paper Title: | Development and Validation of Stability Indicating RP-HPLC Method for Midodrine Hydrochloride in Bulk and Solid Dosage Form |
| Authors Name: | Gauri Rathod , Diksha Ghorpade , Shivani Kotamkar , Samiksha Burange |
| Unique Id: | IJSDR2007014 |
| Published In: | Volume 5 Issue 7, July-2020 |
| Abstract: | The present work involves the development of a stability indicating RP-HPLC assay method for estimation of this drug in bulk and tablets and also to establish the inherent stability of midodrine hydrochloride through stress studies. The present study was undertaken with the primary objective to establish the inherent stability of midodrine hydrochloride through stress studies under a variety of ICH- recommended tests conditions using validated RP-HPLC method. The present work, forced degradation study of midodrine hydrochloride was carried out according to the ICH- guideline Q1A (R2). The drug was subjected to acid (0.1 N HCl), alkaline (0.1 N NaOH) and neutral hydrolysis conditions as well as an oxidative decomposition at 80oC. Photo stability and thermal study was also carried out. The RP- HPLC separate all degradation products formed under various stress condition using a mobile phase, 0.02% triethaylamine: methanol: acetonitrile (20:20:60) pH 4.53 adjusted with acetic acid at a flow rate 1.0 ml/min, on an isocratic HPLC system containing UV-visible detector and hypersil C18 column, detection was carried out at 291 nm. Maximum degradation products were formed under the neutral and oxidative condition while significant degradation was observed in acidic, photolytic, oxidative and thermal conditions respectively. |
| Keywords: | Midodrine hydrochloride, Sstability indicating RP-HPLC, Inherent stability, Photo stability, Validation |
| Cite Article: | "Development and Validation of Stability Indicating RP-HPLC Method for Midodrine Hydrochloride in Bulk and Solid Dosage Form", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.5, Issue 7, page no.125 - 135, July-2020, Available :http://www.ijsdr.org/papers/IJSDR2007014.pdf |
| Downloads: | 000337070 |
| Publication Details: | Published Paper ID: IJSDR2007014 Registration ID:192067 Published In: Volume 5 Issue 7, July-2020 DOI (Digital Object Identifier): Page No: 125 - 135 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
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