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Simultaneous Spectrophotometric Determination of Linagliptin and Metformin Hydrochloride in Combined Tablet Dosage Form


Affiliations
1 Department of Quality Assurance, R.G. Sapkal College of Pharmacy, Anjaneri, Nasik (Dt), India
2 Department of Pharmaceutics , R.G. Sapkal College of Pharmacy, Anjaneri, Nasik (Dt), India
3 Department of Pharmaceutical Sciences, R.G. Sapkal College of Pharmacy, Anjaneri, Nasik (Dt), India
     

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Simple, precise and economical UV Spectrophotometric methods have been developed for the simultaneous estimation of Linagliptin and Metformin in bulk and pharmaceutical dosage forms. The simultaneous equation (Vierodt's Method), which is based on measurement of absorption at 227nm and 232nm i.e. λmax of Linagliptin and Metformin respectively. Linearity was observed in the concentration range of 1-11μg/ml for Linagliptin and 3-13 μg/ml. The accuracy of methods was assessed by recovery studies and was found to be withinrange of 98- 99% for both Linagliptin and Metformin.The developed methods were validated with respect tolinearity, accuracy (recovery), and precision. The method can be employed for estimation of pharmaceuticalformulations with no interference from any other excipients and diluents. The results were validated statistically as per ICH Q2 R1 guidelines and were found to be satisfactory.

Keywords

Linagliptin, Metformin Hydrochloride, ICH, UV-Spectroscopic, Accuracy, Precision.
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  • Simultaneous Spectrophotometric Determination of Linagliptin and Metformin Hydrochloride in Combined Tablet Dosage Form

Abstract Views: 328  |  PDF Views: 5

Authors

Saroj Gajare
Department of Quality Assurance, R.G. Sapkal College of Pharmacy, Anjaneri, Nasik (Dt), India
Amar Zalte
Department of Pharmaceutics , R.G. Sapkal College of Pharmacy, Anjaneri, Nasik (Dt), India
Ravindra B. Saudagar
Department of Pharmaceutical Sciences, R.G. Sapkal College of Pharmacy, Anjaneri, Nasik (Dt), India

Abstract


Simple, precise and economical UV Spectrophotometric methods have been developed for the simultaneous estimation of Linagliptin and Metformin in bulk and pharmaceutical dosage forms. The simultaneous equation (Vierodt's Method), which is based on measurement of absorption at 227nm and 232nm i.e. λmax of Linagliptin and Metformin respectively. Linearity was observed in the concentration range of 1-11μg/ml for Linagliptin and 3-13 μg/ml. The accuracy of methods was assessed by recovery studies and was found to be withinrange of 98- 99% for both Linagliptin and Metformin.The developed methods were validated with respect tolinearity, accuracy (recovery), and precision. The method can be employed for estimation of pharmaceuticalformulations with no interference from any other excipients and diluents. The results were validated statistically as per ICH Q2 R1 guidelines and were found to be satisfactory.

Keywords


Linagliptin, Metformin Hydrochloride, ICH, UV-Spectroscopic, Accuracy, Precision.