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A simple, precise, accurate and rapid HPTLC method has been developed, and validated for the determination of Pioglitazone HCl and Telmisartan simultaneously, in combined dosage form (15 mg and 20 mg). Pioglitazone HCl and Telmisartan was chromatographed on silica Gel 60F₂₅₄ TLC plate using Toluene:ethyl acetate: methanol (7:2:1 v/v) was used as the mobile phase. The R_f value of Pioglitazone HCl and Telmisartan was 0.56±0.04 and 0.23±0.02 and scanned at 254 nm using camag TLC scanner 3. The applicability of the method for simultaneous determinations of Pioglitazone HCl and Telmisartan was verified by the determination of these compounds in marketed tablets. Results of the analysis were validated statistically, and by recovery studies (99.47-101.36% and 99.40-102.37%). The recovery and RSD values were with in limits given in ICH guidelines, method developments indicates that the suitability of proposed for the routine determination of these compounds in tablets. The validation parameters; linearity the range 30-150 ng/spot and 40-200 ng/spot (r=0.9995 and r=0.9996) sensitivity. The limit of detection was found to be 15 ng/spot and 20 ng/spot. The limit of quantification was found to be 45 ng/spot and 60 ng/spot respectively. The accuracy ((99.88% and 99.33%) and reproducibility were found to satisfactory. The proposed method can be successfully used to determine the drug contents on marketed formulation.

Keywords

HPTLC, Pioglitazone HCl, Telmisartan, Methanol, Validation.

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