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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: | Validation of Stability Indicating RP-HPLC method for Simultaneous Estimation of Sitagliptin and Metformin HCl in Pharmaceutical Oral Solid Dosage Form |
| Authors Name: | Kavibharathi Ramalingam , Dr.Shantaram Nangude , Dr. Raja Subburayalu , M.Easter Jayaraj , Dr.R.Sanilkumar |
| Unique Id: | IJSDR2304107 |
| Published In: | Volume 8 Issue 4, April-2023 |
| Abstract: | A Simple, Accurate and Precise Reverse Phase High Performance liquid Chromatography (RP-HPLC) method for the simultaneous estimation of Sitagliptin (SITA) and Metformin HCl (MET) in marketed formulation was developed. The determination was carried out on Chromasol ONYX CN (4.6mm×250mm); 10μm column using a mobile phase Buffer: Acetonitrile (90:10v/v) by isocratic mode. The flow rate was1.0 ml / min with detection at 205nm and 232nm for Sitagliptin and Metformin Hcl.The retention time for Metformin HCl was 2.8 min and for Sitagliptin was 8.6min. Sitagliptin and Metformin HCl showed a linear response in the concentration range Sitagliptin as 5-7.5 μg/ml and Metformin HCl as 80 – 120 μg/ml for Respectively. The correlation co-efficient (' r ' value) for Sitagliptin and Metformin HCl was 1.000 and 0.9999 respectively. The percentage recoveries obtained for Sitagliptin and Metformin HCl ranges 99.7% and 101.1% respectively. The developed method was validated as per ICH Q2 R1 guidelines. For Specificity and linearity, Method Precision (Repeatability), Intermediate Precision (Ruggedness), Accuracy and Robustness the validation results were found well within the limits(%RSD of areas were <2 for assay and recoveries in the range of 98%-102% for assay,r2>0.999) indicating that the developed method is simple, rapid, accurate, precise, specific, robust and economical and less time consuming and was successfully applied for Simultaneous estimation of Sitagliptin and Metformin HCl. |
| Keywords: | RP-HPLC method, Sitagliptin, Metformin HCl, ICH. |
| Cite Article: | "Validation of Stability Indicating RP-HPLC method for Simultaneous Estimation of Sitagliptin and Metformin HCl in Pharmaceutical Oral Solid Dosage Form", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.8, Issue 4, page no.580 - 587, April-2023, Available :http://www.ijsdr.org/papers/IJSDR2304107.pdf |
| Downloads: | 000337070 |
| Publication Details: | Published Paper ID: IJSDR2304107 Registration ID:204916 Published In: Volume 8 Issue 4, April-2023 DOI (Digital Object Identifier): Page No: 580 - 587 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
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