Analytical Method Development and Validation for Simultaneous Determination of Sumatriptan and Naproxen by RP - HPLC

About Author: Rajesh Nuni
Department of Pharmaceutical Analysis,
Vels School of Pharmaceutical Sciences,
Vels University, Pallavaram,
Chennai, Tamilnadu, India

Abstract
A reverse phase HPLC method is developed for the determination of Sumatriptan and naproxen in pharmaceutical dosage forms. Chromatography was carried out on a C8 column [4.6 x 150mm, 3.5mm, Make: XTerra] using a mixture of potassiumdi hydrogen ortho phosphate buffer and acetonitrile (50:50 v/v) as the mobile phase at a flow rate of 0.7ml/min. Detection was carried out at 285 nm. The retention time of the drug Naproxen and sumatriptan was 2.24 minand 5.871 min. The method produced linear responses in the concentration range of 60 to 100μg/ml of Sumatriptan and naproxen. The LOD values for HPLC method for naproxen and sumatriptan were found to be 3.20 and 3.36 ng/ml. The LOQ for Naproxn and Sumatriptan were foud to be 9.86 and 9.90 ng/ml respectively. The method was found to be applicable for determination of the drug in tablets.

Reference ID: PHARMATUTOR-ART-1116

Introduction
Sumatriptan is a salt of 1-{3-[2-(dimethylamino)ethyl]-1H-indol-5-yl}-N-methylmethanesulfonamide. It is used in the treatment of migraine disorder. Naproxen is a salt of 2-(6-methoxynaphthalen-2-yl)propanoic acid used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout. As no HPLC method have been reported for the determination of Sumatriptan and Naproxen an attempt was made to report a simple, reliable and reproducible RP-HPLC method which was duly validated by statistical parameters precision, accuracy, linearity, LOD, LOQ, Robustness and Ruggedness. The method has been satisfactorily applied to the determination of Sumatriptan and Naproxen in pharmaceutical preparations.

Materials & Methods:
Equipments and Apparatus:

Different kinds of equipments viz Analytical weighing balance (shimadzu AUX 200), High performance liquid chromatography(waters, separation module 2695) equipped with Auto Sampler and UV detector. Column Symmetry C8 (4.6 x 150mm, 3.5mm, Make: XTerra),pH meter, Vacuum filter pump (model XI 5522050 of Millipore), Millipore filtration kit, mobile phase reservoir, Water bath, Sample filtration assembly and glassware’s were used throughout the experiment.

Chemicals and solvents:
Potassiumdi hydrogen ortho phosphate and orthophosphoric acid (AR grade, Qualigens) were used for preparing the buffer. HPLC grade acetonitrile (Qualigens) was used for diluent preparation. Pure sample of Sumatriptan and Naproxen was a gift sample from a local pharmaceutical industry. Commercial samples of tablets containing the drug zinc carnosine were purchased from the local pharmacy.

Chromatographic Parameters
Equipment             : High performance liquid chromatography equipped with Auto Sampler and UV detector

Column                  : Symmetry C8 (4.6 x 150mm, 3.5mm, Make: XTerra)

Flow rate               : 0.7 mL per min

Wavelength           : 285 nm

Injection volume    : 20 ml

Column oven         : Ambient

Run time                : 8min

Preparation of mobile phase
Mix a mixture of above buffer 500 mL (50%) and 500 mL of Acetonitrile HPLC (50%) and degas in ultrasonic water bath for 5 minutes. Filter through 0.45 µ filter under vacuum filtration.

Diluent Preparation:
Use the Mobile phase as Diluent

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