RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ALOGLIPTIN AND PIOGLITAZONE IN COMBINED TABLET DOSAGE FORM
Manzoor Ahmed, Anusha.M*, Satishkumar Shetty.A, Kuppast I.J, Siddalingaswamy.M.S, Ravi M.C
ABSTRACT
The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method with subsequently validate as per ICH guidelines for the determination of Alogliptin (ALO) and Pioglitazone (PIO) using mobile phase [mixture of Phosphate buffer- pH-3.6 and acetonitrile in the ratio of 35:65] as the solvent. The proposed method involves the measurement of Retention time at selected analytical wavelength. 268.0 nm was selected as the analytical wavelength. The retention time of ALO and PIO was found to be 3.113 and 5.234 respectively. The linearity of the proposed method was investigated in the range of 2.5-15 μg/ml (r = 0.9998) for ALO and 03-18μg/ml (r = 0.9999) for PIO 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.
Keywords: HPLC Method, Alogliptin , Pioglitazone, Validation.
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