Informatics Publishing Limited

Snehal S. Ingale ¹, Dipali M. Mehetre ¹, Dhanshri J. Desai ¹, Madhusmita Sahoo ¹, Vishnu P. Choudhari ¹, Bhanudas S. Kuchekar ¹

Affiliations
1 MAEER’S Maharashtra Institute of Pharmacy, S.No. 124, MIT Campus, Paud Road, Kothrud, Pune-411038 (MS), IN

Abstract

Two simple, economical, precise and accurate methods for simultaneous determination of Drotaverine Hydrochloride (DRO) and Diclofenac Potassium (DIC) in combined tablet dosage form has been developed. The first method is based on Ratio Spectra Derivative and second method is Area Under Curve (AUC) Spectrophotometry. The amplitudes at 251.96 nm and 258.46 nm in the first derivative ratio spectra were selected to determine DRO and DIC, respectively and wavelength ranges of 237.4-247.2 nm and 271.1-282.8 nm were selected to determine DRO and DIC by AUC method, respectively in combined formulation. Beer’s law is obeyed in the concentration range of 8-40 μg mL^-1 for DRO and 5-25 μg mL^-1 for DIC for both the methods. The % assay for commercial formulation was found to be in the range 99.01 – 100.89% for DRO and 98.91 – 101.72% for DIC by the proposed methods. ICH guidelines were followed and methods were validated with respect to linearity, precision and accuracy. Recovery by both the methods was found in the range of 99.72 - 101.34% for DRO and 99.06 - 100.45% for DIC.

Keywords

Drotaverine Hydrochloride, Diclofenac Potassium, Ratio Spectra Derivative Spectrophotometry, Area Under Curve.

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Atul H. Kategaonkar ¹, Dhaval M. Patel ¹, Bhushan P. Itkar ¹, Vishnu P. Choudhari ¹, Bhanudas S. Kuchekar ¹, Ana G. Nikalje ²

Affiliations
1 MAEER’S Maharashtra Institute of Pharmacy, S.No. 124, MIT Campus, Paud Road, Kothrud, Pune-411038, IN
2 Post-Graduate Department of Pharmaceutical Chemistry, Y.B. Chavan College of Pharmacy, Dr. Rafiq Zakaria Campus, Rauza Bagh, Aurangabad-431001, MS, IN

Abstract

Simple, accurate, precise, and sensitive ultraviolet spectrophotometric and stability indicating reversed phase high performance liquid chromatographic methods for simultaneous estimation of Tamsulosin and Finasteride in combined tablet dosage form have been developed and validated. The spectroscopic method employs an absorbance correction method using 228 and 246 nm as two wavelengths for estimation with methanol as solvent. Beer's law is obeyed in the concentration range of 2-10 and 25-125 μg/mL for Tamsulosin and Finasteride respectively. The reversed phase high performance liquid chromatographic separation was achieved on a Waters Symmetry C₁₈ column (250 mm×4.6 mm, 5.0 μ particle size) using Methanol:Water:THF (75:15:10 v/v/v) mobile phase. Trifluoroacetic was used to adjusted pH to 3.7 with, flow rate was 0.7 mL/min and column temperature was maintained at 32°C. Quantification was achieved with PDA detector at 275 nm over the concentration range of 50 to 400 μg/mL for Finasteride and 4 to 44 μg/mL for Tamsulosin. Both methods have been successfully applied for the analysis of the drugs in a pharmaceutical formulation. Results of analysis were validated statistically and by recovery studies.

Keywords

Spectrophotometry, Stability Indicating RP-HPLC, Tamsulosin, Finasteride.

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