Development and Validation of Linagliptin and Metformin hydrochloride in Bulk and Combined Tablet Dosage Form by using UV Spectrophotometric Method.

Abstract

A new simple, economical UV method have been developed for the determination of Linagliptin and Metformin Hydrochloride in bulk and pharmaceutical dosage form. The maximum absorption of Linagliptin was found to be at 295nm and Metformin hydrochloride at 234nm. Methanol and Water in the ratio 40: 60 was used as a diluent. The calibration curve was linear over the concentration range of and 3 to 11 μg/ml for Linagliptin and Metformin hydrochloride respectively. The linear correlation was found (r2) in the range of 0.9987 and 0.9947 for linaglitin and metformin hydrochloride in API and MKTD respectively. The proposed method was validated as per ICH guidelines parameters like linearity, precision, accuracy, robustness, ruggedness. The accuracy of these methods were evaluated by recovery studies and good recovery result were obtained 97.88–102.11% and 95.77–100.78%. The method was successfully applied for determination of Linagliptin and Metformin hydrochloride in their combined tablet dosage form.