Development and Validation of Stability-Indicating HPTLC Determination of Tamsulosin in Bulk and Pharmaceutical Dosage Form

الملخص EN

A simple, economic, selective, precise, and stability-indicating high-performance thin-layer chromatographic method for analysis of tamsulosin hydrochloride, both as a bulk drug and in formulations, was developed and validated according to ICH guidelines.

The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase while the solvent system consisted of toluene : methanol : triethylamine (3.5 : 1.2 : 0.2 v/v).

The system was found to give compact spot for drug (Rf value of 0.52 ± 0.02).

Densitometric analysis of tamsulosin was carried out in the absorbance mode at 280 nm.

The linear regression analysis data for the calibration plots showed good linear relationship, r2=0.9982±0.0012, with respect to peak area in the concentration range 400–2400 ng per spot.

The mean value ± SD of slope and intercept were 2.6553 ± 0.0173 and 777.7 ± 74.8 with respect to peak area.

The method was validated for precision, recovery, and robustness.

The limits of detection and quantitation were 20.49 and 62.10 ng per spot, respectively.

Tamsulosin was subjected to hydrolysis, oxidation, and thermal degradation which indicate the drug is susceptible to hydrolysis, oxidation, and heat.

Statistical analysis proves that the method is repeatable, selective, and accurate for the estimation of tamsulosin.