Author(s): Patil Pallavi M, Mayur Tekade, Samiksha Agarkar, Mohamad Taleuzzaman


DOI: 10.52711/0974-360X.2023.00385   

Address: Patil Pallavi M1*, Mayur Tekade2, Samiksha Agarkar3, Mohamad Taleuzzaman4
1,2,3P.E. Society’s Modern College of Pharmacy, Yamunanagar, Nigdi, Pune-411044 Maharashtra, India, 411044.
4Maulana Azad University, Village Bujhawar, Tehsil Luni Jodhpur 342802.
*Corresponding Author

Published In:   Volume - 16,      Issue - 5,     Year - 2023

The samples were applied on to the plate in the form of band with band length of 5mm. The mobile phase consisted of Chloroform: Methanol in the ratio of 8:2 v/v and 10ml of the mobile phase was used in each chromatographic run. Ascending development technique was carried out in a twin trough chamber saturated with mobile phase vapours for 15 min. The multiple wavelength detector was set at 216 nm, and quantification of the analyte was based on measuring its peak area. Rf for NTG was about 0.59. Calibration curve of NTG was linear in the range 100–600µg/band with correlation coefficient >0.9994. The drug was subjected to forced-degradation conditions of reaction, oxidization and dry heat. Unknown impurity was found in Nateglinide industrial batch stability condition at levels more than 0.1% in HPTLC analysis was characterized preliminarily by ESI-MS/MS studies. The major unknown (unknown-1 and 2) were enriched and isolated by preparative LC and structure was evidenced by 1H NMR spectroscopy, mass spectrometry and FT-IR. This technique will be used for the standard management of each drug substance and drug product. Finally, the projected method made use of hyphenated techniques as a tool for peak identity and purity confirmation.

Cite this article:
Patil Pallavi M, Mayur Tekade, Samiksha Agarkar, Mohamad Taleuzzaman. Isolation and Characterisation of Nateglinide and its impurity in Bulk and Marketed Formulation by HPTLC Method. Research Journal of Pharmacy and Technology 2023; 16(5):2343-6. doi: 10.52711/0974-360X.2023.00385

Patil Pallavi M, Mayur Tekade, Samiksha Agarkar, Mohamad Taleuzzaman. Isolation and Characterisation of Nateglinide and its impurity in Bulk and Marketed Formulation by HPTLC Method. Research Journal of Pharmacy and Technology 2023; 16(5):2343-6. doi: 10.52711/0974-360X.2023.00385   Available on:

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