Bassam M. AYOUB, Rola M EMAM, Mahmoud M. YOUSSEF, Muhammad N. EL-KATTAN, Marwa A. SAYED, Ahmed M. KOWİDER, Adly H. SEHA, Engy A. RABEA, Rana M. YAKOUT, Rolly H. FARİED

Mean Centering Method for determination of Empagliflozin and Metformin

Introduction of computer-assisted analysis to pharmaceutical products is considered a significant approach. A new method was developed for simultaneous determination of empagliflozin and metformin manipulating their ratio spectra with application on recently approved pharmaceutical combination, Synjardy tablets. Spiking technique was used to increase the concentration of empagliflozin after extraction from tablets to allow its simultaneous determination with metformin without prior separation. Validation parameters according to ICH guidelines were acceptable over the concentration range of 2-12 μg/mL for both drugs. Mean centering was performed using Minitab program. Using computer assisted programs after spiking accompanied with direct UV measurement of the drugs was satisfactory for accurate assay without complex instrumentations. The optimized method was proved to be suitable for industrial QC labs.

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Neeland IJ, Salahuddin U, Mcguire DK. A safety evaluation of empagliflozin for the treatment of type 2 diabetes. Expert Opin Drug Saf 2016; 15: 393-402.

Ayoub BM. UPLC simultaneous determination of empagliflozin, linagliptin and metformin. RSC Adv 2015; 5: 95703-9.

Ayoub BM. Development and validation of simple spectrophotometric and chemometric methods for simultaneous determination of empagliflozin and metformin: Applied to recently approved pharmaceutical formulation. Spectrochim Acta MolBiomol. Spectrosc 2016; 168:118-22.

Hegazy MAM, Fayez YM. Mean centering of ratio spectra and concentration augmented classical least squares in a comparative approach for quantitation of spectrally overlapped bands of antihypertensives in formulations. Spectrochim Acta Mol Biomol Spectrosc 2015; 140: 210-5.

Padmaja N, Veerabhadram G. Development and validation of analytical method for Simultaneous estimation of Empagliflozin and Linagliptin in bulk drugs and combined dosage forms using UV-visible spectroscopy. Pharm Lett 2015; 7:306-12.

Banik S, Karmakar P, Miah MD. Development and validation of a UV-spectrophotometric method for determination of vildagliptin and linagliptin in bulk and pharmaceutical dosage forms. Bangladesh Pharm J 2015; 18: 163-8.

Sekhar CK, Sudhakar P, Rao TM, Babu PV, Manikanta KA. A new UV-Method for determination of linagliptin in bulk and pharmaceutical dosage form. IJUPBS 2013; 2: 1-6.

Supriya P, Madhavi Latha N, Rohith KBV, Ramana GV, Harini U, Pawar AKM. Development and validation of UV spectrophotometric and reversed phase-high performance liquid chromatography-PDA methods for the estimation of alogliptin benzoate. Asian J Pharm Clin Res 2016; 9: 264-9.

Sen DB, Sen AK, Zanwar A, Balaraman R, Seth AK. Determination of alogliptin benzoate and metformin hydrochloride in tablet dosage form by simultaneous equation and absorption ratio method. Int J Pharm Pharm Sci 2015; 7: 380-3.

Yadav PJ, Kadam VN, Mohite SK. Development and validation of UV spectrophotometric method for alogliptin benzoate in bulk drug and tablet formulation. J Curr Pharm Res 2014; 4: 1286-90.

Ayoub BM. Linagliptin: A concise review on analytical and bio-analytical methods. Der Pharma Chem 2016; 8: 23-9.

Note for guidance on validation of analytical procedures: Methodology (ICH harmonised tripartite guideline Q2B). Pharm Ind 1997; 59:107-10.