• Asmita Mahendrabhai Patel
• Mrs. Vidhi Kotadiya
• Dr. Neha Tiwari
• Dr. Pragnesh Patani

Abstract A simple, rapid, precise and reliable RP-HPLC method was developed for Simultaneous estimation of Repaglinide and Voglibose in pharmaceutical dosage form. The method is based of precolumn derivatization of Voglibose with 9- Fluorenyl methyl oxycarbonyl chloride (FMOC - chloride) due to lack of chromophoric group it cannot directly estimated by UV detector in RP-HPLC method. Precolumn derivatization (PCD) conditions were optimized by evaluating the parameters such as concentration of borate buffer, concentration of FMOC-Cl and reaction time of derivatization. The chromatographic separation was achieved on Hypersil BDS C18 (250mm x 4.6mm, 5μm) column and Buffer (0.5M potassium dihydrogen ortho phosphate, pH was adjusted with 1% orthophosphoric acid, Buffer, (pH3.5): methanol (30:70v/v) as a mobile phase at a flow rate of 1ml/min. detection was carried out at 240nm. The Retention time of Repaglinide- 3.670 and Voglibose- 5.333minute. The method has been validated for linearity, accuracy and precision. Linearity observed for Repaglinide 7.5-22.5 μg/ml and Voglibose 4.5-13.5 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Repaglinide and Voglibose in its Tablet. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and proposed method was successfully applied for the simultaneous estimation of the drugs in commercial combined dosage form.

Keyword: Repaglinide, Voglibose, Derivatization, FMCO-cl, Analytical Method, Validation, Stability.

"DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP- HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF REPAGLINIDE AND VOGLIBOSE IN ITS TABLET DOSAGE FORM.", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.8, Issue 5, page no.g92-g100, May-2021, Available :http://www.jetir.org/papers/JETIR2105806.pdf

"DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP- HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF REPAGLINIDE AND VOGLIBOSE IN ITS TABLET DOSAGE FORM.", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.8, Issue 5, page no. ppg92-g100, May-2021, Available at : http://www.jetir.org/papers/JETIR2105806.pdf