DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TENELIGLIPTIN AND PIOGLITAZONE HCL IN BULK AND THEIR PHARMACEUTICAL DOSAGE FORM

Rajendra Patel*, Darpini Patel and Devendra Parmar

ABSTRACT

Teneligliptin and Pioglitazone hydrochloride are prescribed in a combination dose form for the treatment of type II diabetes mellitus. A high-performance liquid chromatography method was developed and validated for the simultaneous quantification of teneligliptin and pioglitazone HCl that are supplied in a combination tablet form. A shimpack solar C18 column of (250mm x 4.5mm x 5 µm) is employed, with an injection loop capacity of 10 µl and an ultraviolet detection at 238 nm, and flow rate of 1.0 ml/min. A low-pressure gradient mobile phase of acetonitrile:5 mM phosphate buffer (pH 3.5) in a ratio of (90:10 v/v) was used to perform the RP-HPLC separation. Studies on forced degradation were conducted in thermal, photolytic, peroxide, acid, and base media. Pioglitazone and teneligliptin were shown to have retention times of 3.81 and 6.90 minutes, respectively. Teneligliptin and pioglitazone HCl were shown to have a linearity range of 2–12 µg/ml. Method validation followed ICH guidelines. The developed RP-HPLC method was proven to be sensitive, specific, accurate, and precise. It may be applied to routinely analysis of pharmaceutical formulations containing teneligliptin and pioglitazone HCl. The investigation on forced degradation came to the conclusion that the developed method successfully separated medicinal compounds from degradation products produced under different stress conditions.

Keywords: Teneligliptin; Pioglitazone HCl; RP-HPLC; Stability, Validation.