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IJNRD
INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT
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ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016
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Paper Title: STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR QUANTITATIVE ESTIMATION OF PIOGLITAZONE AND VILDAGLIPTIN IN SYNTHETIC MIXTURE
Authors Name: Nidhi Jamin Shah
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IJNRD_197046
Published Paper Id: IJNRD2305785
Published In: Volume 8 Issue 5, May-2023
DOI:
Abstract: The RP-HPLC was used to develop the method and for validation of Pioglitazone and Vildagliptin from synthetic mixture. For chromatographic condition the mobile phase used was Acetonitrile: Methanol: Water (20:40:40 v/v) on the stationary phase of Hypersil ODS C18 column (250 mm*4.6 mm), the detection observed was at 210nm.Forced degradation study was performed by applying stress condition like Acid hydrolysis, Oxidation, Alkali Hydrolysis and Thermal Degradation. The response of the calibration curve was found to be linear in range by Pioglitazone and Vildagliptin 0.9989 and 0.9975 respectively. The retention time observed is 2.324 min for Pioglitazone and 4.241 min for Vildagliptin at the run time of 15 minutes. The limit of detection for Pioglitazone is 0.42 µg/mL and Vildagliptin is 2.017 µg/mL. However, the limit of quatification for pioglitazone is 1.28 µg/mL and Vildagliptin is 6.11 µg/mL. The accuracy for the pioglitazone is 99.14% and Vildagliptin is 99.26% as per method performed. The limit for precision is RSD<2 therefore, for pioglitazone is 0.83-1.03 and vildagliptin is 0.87-1.20. The experiment was carried out as per International Conference on Harmonization (ICH) guidelines and the statistical analysis of the data is linear, precise, accurate and robust. Therefore, the method can be successfully employed for the synthetic mixture of Pioglitazone and Vildagliptin in pharmaceutical formulation.
Keywords: Pioglitazone, Vildagliptin, RP-HPLC, Forced Degradation
Cite Article: "STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR QUANTITATIVE ESTIMATION OF PIOGLITAZONE AND VILDAGLIPTIN IN SYNTHETIC MIXTURE", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 5, page no.h620-h643, May-2023, Available :http://www.ijnrd.org/papers/IJNRD2305785.pdf
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ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
Publication Details: Published Paper ID:IJNRD2305785
Registration ID: 197046
Published In: Volume 8 Issue 5, May-2023
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Page No: h620-h643
Country: Ahmedabad, Gujarat, India
Research Area: Pharmacy
Publisher : IJ Publication
Published Paper URL : https://www.ijnrd.org/viewpaperforall?paper=IJNRD2305785
Published Paper PDF: https://www.ijnrd.org/papers/IJNRD2305785
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ISSN: 2456-4184
Impact Factor: 8.76 and ISSN APPROVED
Journal Starting Year (ESTD) : 2016

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