Asian Journal of Pharmaceutical Analysis

Vedantika Das ¹, Ashwini Sambherao ¹, Saroj Gajare ¹, Amar Zalte ¹, R. B. Saudagar ¹

Affiliations
1 Department of Quality Assurance, Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nasik, IN

Abstract

A simple, accurate, precise, and sensitive a highly selective ultra violet spectrophotometric method has been developed for the validation and estimation in bulk and dosage form. It shows maximum absorbance 286 nm. Beer-Lambert's was obeyed in the concentration range of in the range of 15-55μg/ml. The method was successfully validated in accordance to ICH guideline for accuracy, precision, linearity and robustness. The linear regression analysis data for calibration plots showed good linear relationship and obtain correlation factor 0.9927 for Drotaverine. Thus method was successfully applied for routine analysis of Drotaverine in bulk samples.

Keywords

Drotaverine, ICH, UV- Spectroscopy, Accuracy, Precision.

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Saroj Gajare ¹, Amar Zalte ², Ravindra B. Saudagar ³

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

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.

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