Analytical Method Development and Validation for the Determination of Diclofenac Sodium, Vitamin B1, Vitamin B6 and Vitamin B12 in Soft Gelatin Capsule Dosage Form

Analytical Method Development and Validation for the Determination of Diclofenac Sodium, Vitamin B1, Vitamin B6 and Vitamin B12 in Soft Gelatin Capsule Dosage Form


Vinod J, Saikesavan M, Kamalakkannan V


Abstract

An accurate, simple, sensitive and selective reverse phase liquid chromatographic method has been developed for the determination of Diclofenac sodium, Vitamin B1, Vitamin B6 and Vitamin B12 in their pharmaceutical preparations. The determination of Diclofenac sodium was carried out on Phenomenex ODS, C-18 (150 x 4.6 mm) 5μ column using a mobile phase consisting of buffer: acetonitrile (40:60). The flow rate and run time were 1ml/min and 10 minutes respectively. The wavelength was 254 nm. The determination of Vitamin B1 and B6 was carried out on Inertsil ODS, C18 column (250 x 4.6mm;5µm) using a mobile phase consisting of a mixture of 1000mL of Sodium 1-hexane sulfonic acid solution, 730mL of water, 270mL glacial acetic acid of and 10ml of methanol. The flow rate and run time were 1.5ml/min and 10 minutes respectively. The wavelength was 284 nm. The determination of Vitamin B12 was carried out on Phenomenox ODS, C-18 column (150x4.6mm;5µm) using a mobile phase consisting of a mixture of water: acetonitrile (87:13) containing 0.25mL of Trifluroacetic acid. The flow rate and run time were 1.2ml/min and 10 minutes respectively. The wavelength was 361 nm. The developed method was found to be simple, specific, robust, linear, precise, and accurate for the determination of Diclofenac sodium, Vitamin B1, Vitamin B6 and Vitamin B12 in pharmaceutical formulations.


Keywords

Diclofenac sodium, Vitamin B1, Vitamin B6 and Vitamin B12, Reverse phase chromatographic technique, Method validation


Cite This Article

Vinod J, Saikesavan M, Kamalakkannan V, Analytical Method Development and Validation for the Determination of Diclofenac Sodium, Vitamin B1, Vitamin B6 and Vitamin B12 in Soft Gelatin Capsule Dosage Form, International Journal for Pharmaceutical Research Scholars, 2013, 2(4), 312-327.

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