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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: | HPLC: METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION STUDY FOR SIMULTANEOUS ESTIMATION OF HYDROCORTISONE ACETATE AND ATROPINE SULPHATE IN MARKETED FORMULATION |
| Authors Name: | Saloni Desai , Dr.Alisha Patel |
| Unique Id: | IJSDR2311092 |
| Published In: | Volume 8 Issue 11, November-2023 |
| Abstract: | The objective of this study was to develop and validate a method for simultaneous estimation of Hydrocortisone acetate and Atropine sulphate in Marketed Formulation. An Isocratic HPLC analysis method using a reverse phase Inertsil 3V ODS (250 mm × 4.6 mm, 5 µm) and Mobile phase 0.1M 1-Heptane sulfonic acid buffer (pH 4 adjusted with 0.025% OPA): Methanol: Acetonitrile (35:45:20 v/v) was developed, optimized and validated. Analysis were carried out at flow rate 1 ml/min and monitored at 224 nm. Retention time of Hydrocortisone acetate, Atropine sulphate, is about 8.2316 and 4.575 min respectively. Linearity of Hydrocortisone acetate 7.5-30 μg/mL and Atropine sulphate was 15-60 μg/mL. The developed methods have been validated statistically as per ICH guidelines. The method showed good reproducibility and recovery with %RSD less than 2. So, the proposed methods were found to be simple, specific, precise, accurate and linear. Forced degradation study was carried out and there is no interference of excipients or degradation products. Hence it can be applied for routine analysis of Hydrocortisone acetate, Atropine sulphate in Marketed formulation. |
| Keywords: | Hydrocortisone acetate, Atropine sulphate, Method development and Validation, Forced degradation |
| Cite Article: | "HPLC: METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION STUDY FOR SIMULTANEOUS ESTIMATION OF HYDROCORTISONE ACETATE AND ATROPINE SULPHATE IN MARKETED FORMULATION", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.8, Issue 11, page no.624 - 632, November-2023, Available :http://www.ijsdr.org/papers/IJSDR2311092.pdf |
| Downloads: | 000338719 |
| Publication Details: | Published Paper ID: IJSDR2311092 Registration ID:209390 Published In: Volume 8 Issue 11, November-2023 DOI (Digital Object Identifier): Page No: 624 - 632 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
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