Selective SGLT2 Inhibitor’s Estimation and Validation from Galenical Form by RP-HPLC Method
Swapnali Suresh Mankar
*
Department of Chemistry, Datta Meghe College of Pharmacy, Datta Meghe Institute of Medical Science(DU),Wardha 442004, Maharashtra, India.
Muhammad Younas
Department of Doctor of Pharmacy, Balkh University, Mazar-e-Sharif, Afghanistan.
Vaishavi Kalode
Department of Pharmacology, Datta Meghe College of Pharmacy, Datta Meghe Institute of Medical Science(DU),Wardha 442004, Maharashtra, India.
Pranita Jirvankar
Department of Chemistry, Datta Meghe College of Pharmacy, Datta Meghe Institute of Medical Science(DU),Wardha 442004, Maharashtra, India.
Prasanna Phutane
Department of Pharmaceutics, Datta Meghe College of Pharmacy, Datta Meghe Institute of Medical Science(DU),Wardha 442004, Maharashtra, India.
Shital Chandewar
Department of Pharmaceutics, Datta Meghe College of Pharmacy, Datta Meghe Institute of Medical Science(DU),Wardha 442004, Maharashtra, India.
Ashwini Armarkar
Department of Pharmcognosy, Datta Meghe College of Pharmacy, Datta Meghe Institute of Medical Science(DU), Wardha 442004, Maharashtra, India.
Anil Pethe
Datta Meghe College of Pharmacy, DMIMSU, Wardha 442004, Maharashtra, India.
*Author to whom correspondence should be addressed.
Abstract
Aim: The recent analysis is required to do novel and simple, sensitive, precise, efficient, instant and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for estimation of antidiabetic drug in the unit dosage form. Validation of this method is also planned to make it suitable for the actual use.
Study Design: Department of Pharmaceutical Chemistry, Datta Meghe Institute of Medical Sciences deemed to be university, Wardha in collaboration with Balkh university, Mazar-e-sharif, Afghanistan between August 2021 and December 2021.
Methodology: In that article develop the method and validate it by estimation of antidiabetic drugs in solid dosage form by RP-HPLC, by using System suitability test, Repeatability, Precision studies (Intra-day and Interday/Intermediate), Linearity/Calibration studies, Robustness, Force degradation, Specificity, Drug recovery/accuracy studies.
Results: as per ICH guidelines, the performance if system suitability in remogliflozin were achieved all guidelines; in that, tailing factor (T),separation factors(α),theoretical plates(N),capacity factor (k’), resolution (R) and RSD (%). The validated stress degradation studies under thermal, oxidative, alkali and acid, in few degradation products for remogliflozin (REM).
Conclusion: From the results we conclude that, this novel technique which validated for exploration by reverse phase high performance liquid chromatography (RP-HPLC) should be used for routine quality control of remogliflozin (REM) prediction from developed formulation.
Keywords: Antidiabetic, remogliflozin, stress degradation, high performance liquid chromatography