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Title: :  METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC METHOD
PaperId: :  25623
Published in:   International Journal Of Advance Research And Innovative Ideas In Education
Publisher:   IJARIIE
e-ISSN:   2395-4396
Volume/Issue:    Volume 11 Issue 1 2025
DUI:    16.0415/IJARIIE-25623
Licence: :   IJARIIE is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.

Author NameAuthor Institute
Akanksha.S.NirmalPravara Rural College of pharmacy, Pravaranagar
PROF.MAYUR BHOSALEPravara Rural College of pharmacy, Pravaranagar

Abstract

B pharmacy
Stability-indicating methods, High-Performance Liquid Chromatography, Forced degradation studies, Method validation, Regulatory guideline, Dru plsg stability
This review focuses on the development and validation of stability-indicating analytical methods (SIAMs) using High-Performance Liquid Chromatography (HPLC), a key tool in pharmaceutical quality control. Stability-indicating methods are essential for monitoring the stability of active pharmaceutical ingredients (APIs) and detecting degradation products under stressed conditions, such as light, heat, humidity, and pH fluctuations. The methodology involves forced degradation studies to identify degradation pathways and optimize chromatographic conditions, including mobile phase composition, column type, and flow rate, to ensure efficient separation of APIs from their degradation products. The validation of these methods, based on regulatory guidelines from the International Council for Harmonisation (ICH) and the U.S. Food and Drug Administration (FDA), ensures accuracy, precision, specificity, linearity, and detection limits. These parameters are critical for confirming that the analytical methods provide reliable, reproducible results suitable for pharmaceutical stability testing. This review also highlights the increasing importance of advanced techniques such as Ultra-High Performance Liquid Chromatography (UHPLC) and mass spectrometry (MS) to enhance sensitivity and detection capabilities.

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IJARIIE Akanksha.S.Nirmal, and PROF.MAYUR BHOSALE. "METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC METHOD" International Journal Of Advance Research And Innovative Ideas In Education Volume 11 Issue 1 2025 Page 214-234
MLA Akanksha.S.Nirmal, and PROF.MAYUR BHOSALE. "METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC METHOD." International Journal Of Advance Research And Innovative Ideas In Education 11.1(2025) : 214-234.
APA Akanksha.S.Nirmal, & PROF.MAYUR BHOSALE. (2025). METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC METHOD. International Journal Of Advance Research And Innovative Ideas In Education, 11(1), 214-234.
Chicago Akanksha.S.Nirmal, and PROF.MAYUR BHOSALE. "METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC METHOD." International Journal Of Advance Research And Innovative Ideas In Education 11, no. 1 (2025) : 214-234.
Oxford Akanksha.S.Nirmal, and PROF.MAYUR BHOSALE. 'METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC METHOD', International Journal Of Advance Research And Innovative Ideas In Education, vol. 11, no. 1, 2025, p. 214-234. Available from IJARIIE, http://ijariie.com/AdminUploadPdf/METHOD_DEVELOPMENT_AND_VALIDATION_BY_RP_HPLC_METHOD_ijariie25623.pdf (Accessed : 29 April 2025).
Harvard Akanksha.S.Nirmal, and PROF.MAYUR BHOSALE. (2025) 'METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC METHOD', International Journal Of Advance Research And Innovative Ideas In Education, 11(1), pp. 214-234IJARIIE [Online]. Available at: http://ijariie.com/AdminUploadPdf/METHOD_DEVELOPMENT_AND_VALIDATION_BY_RP_HPLC_METHOD_ijariie25623.pdf (Accessed : 29 April 2025)
IEEE Akanksha.S.Nirmal, and PROF.MAYUR BHOSALE, "METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC METHOD," International Journal Of Advance Research And Innovative Ideas In Education, vol. 11, no. 1, pp. 214-234, Jan-Feb 2025. [Online]. Available: http://ijariie.com/AdminUploadPdf/METHOD_DEVELOPMENT_AND_VALIDATION_BY_RP_HPLC_METHOD_ijariie25623.pdf [Accessed : 29 April 2025].
Turabian Akanksha.S.Nirmal, and PROF.MAYUR BHOSALE. "METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC METHOD." International Journal Of Advance Research And Innovative Ideas In Education [Online]. volume 11 number 1 (29 April 2025).
Vancouver Akanksha.S.Nirmal, and PROF.MAYUR BHOSALE. METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC METHOD. International Journal Of Advance Research And Innovative Ideas In Education [Internet]. 2025 [Cited : 29 April 2025]; 11(1) : 214-234. Available from: http://ijariie.com/AdminUploadPdf/METHOD_DEVELOPMENT_AND_VALIDATION_BY_RP_HPLC_METHOD_ijariie25623.pdf
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