RP-HPLC Method Development and Validation for Simultaneous Estimation of Linagliptin and Metformin Hydrochloride in Combined Tablet Dosage Form
Keywords:
RP – HPLC, Linagliptin, Metformin Hydrocholiride, ValidationAbstract
The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method with subsequently validateas per ICH guidelines for the determination ofLinagliptin(LIN) and Metformin hydrochloride (MET) using mobile phase [mixture of Phosphate buffer- pH-3.6 and acetonitrile in the ratio of 65:35] as the solvent. The proposed method involves the measurement of Retention time at selected analytical wavelength. 235.0 nmwas selected as the analytical wavelength.The retention time of LIN and MET was found to be 5.055 and 2.838 respectively. The linearity of the proposed method was investigated in the range of 1-5 µg/ml (r= 0.9998) for LIN and 10-50µg/ml (r= 0.9999) for MET respectively. The method was statistically validated for its linearity, accuracy and precision. Both inter-day and intra-day variation was found to be showing less % RSD (Relative Standard Deviation) value indicating high grade of precision of the method.
References
Amar Gangadhar Zalte, Ravindranath Bhanudas Saudagar, Pramod Nanasaheb Katkade, (2016). Validated UV spectroscopic estimation of Linagliptin concentration in bulk and dosage forms, Volume - 9, Issue 5.
John H B, John M B. (2004). Wilson & Gisvold’s textbook of Organic medicinal and Pharmaceutical Chemistry. 11th ed.; p. 672.
Laurene L B, Jhon S L, Keith L P. (2006). Goodman and Gilman’s the pharmacological basis of Therapeutics. 11th ed. Mc Graw Hill, New York, U.S.A; p. 1638-39.
Maria C R, Mihaela I, Lavinia H, Elena I, Valentina A, Aurelian E R. et al. Constantin M. (2009). Validation of a HPLC method for the simultaneous analysis of Metformin and Gliclazide in human plasma. FARMACIA.; 57(6):728-35.
Ramzia I. E., Ehab F. E., Bassam M. A. (2012). Liquid Chromatographic determination of Linagliptin in bulk and in its pharmaceutical preparation. Int J Biomed Sc, 8( 3):215-8.
Sujana K, Swathi R G, Bhanu P M, Saheethi R M. (2010). Simultaneous estimation of Pioglitazone Hydrochloride and Metformin Hydrochloride using UV spectroscopic method in tablet dosage form. J Biomed Sci & Res.; 2(2):110-5.
Wanjari M M, There A W, Tajne M R, Chopde C T, Umathe S N. (2008). Rapid and simple RPHPLC method for the estimation of Metformin in rat plasma. Indian J Pharm Sci. 70(2):198-202.
