Monday , 26 February 2024

RP-HPLC Method for Simultaneous Estimation of Tamsulosin and Finasteride in Bulk and Pharmaceutical Dosage Forms

Motupalli Surya Hyma Satyavathi1*, Gope Edward Raju2, Kandregula Uma Maheswari3, Doonaboyina Raghava4, Kavala Nageswara Rao5
Department of Pharmaceutical Analysis, K.G.R.L College of Pharmacy, Bhimavaram-534201, Andhra Pradesh, India

A b s t r a c t
A new method was established for simultaneous estimation of Tamsulosin and Finasteride by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Tamsulosin and Finasteride by using Agilent C18 column (4.6×150mm) 5µ, flow rate was 1ml/min, mobile phase ratio was (60:40 v/v) methanol: phosphate buffer, detection wavelength was 256nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.327 mins and 4.342 mins. The % purity of Tamsulosin and Finasteride  was found to be 99.84% and 100.14% respectively. The system suitability parameters for Tamsulosin and Finasteride such as theoretical plates and tailing factor were found to be 2937, 1.3 and 2300 and 1.3, the resolution was found to be 4.6. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Tamsulosin and Finasteride was found in concentration range of 50µg-250µg and 10µg-50µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 100.07% and 100.06%, %RSD for repeatability was 0.3 and 0.39, % RSD for intermediate precision was 0.1 and 0.16 respectively. The precision study was precise, robust and repeatable. LOD value was 3.041 and 3.08 and LOQ value was 9.79 and 10.37 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Tamsulosin and Finasteride in API and Pharmaceutical dosage form.
Keywords: C18 column, Phosphate buffer, Tamsulosin and Finasteride, RP-HPLC

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