Asian Journal of Research in Chemistry

Somsubhra Ghosh ¹, B. Anusha ¹, Santhoshi ¹, David Banji ¹, Y. Chaithanya Kumar ¹, P. Raghavendra ¹, Subhadip Roy ²

Affiliations
1 Nalanda College of Pharmacy, Nalgonda, Andhra Pradesh, 508001, IN
2 Mylan Laboratories Ltd, Hyderabad, Andhra Pradesh, IN

Abstract

A new simple, accurate, rapid and precise isocratic High Performance Liquid Chromatographic (HPLC) method was developed and validated for the determination of Aliskiren Hemifumarate (ALSK) and Valsartan (VAL) in bulk drug. The Method employs Waters HPLC system on C8 Column (4.6 x 250 mm, 5 μm) and flow rate of 1 ml/min with a load of 10μl. The Detection was carried out at 220 nm. mobile phase used as Acetonitrile and Phosphate buffer and Methanol was used as mobile phase in the composition of 45:40:15 , phosphate buffer (0.02Mm) adjusted the pH to 4 with Orthophosphoric acid within a short runtime of 8 min. The retention times of Aliskiren (ALSK) was 3.407 min, Valsartan (VAL) was 4.268 min. The method was validated according to the regulatory guidelines with respect to specificity, precision, accuracy, linearity and robustness etc.

Keywords

Aliskiren Hemifumarate, Valsartan, HPLC, Validation

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M. Alagar Raja ¹, Godavari Swetha ¹, David Banji ¹, S.S. Gosh ¹, C. Vanitha ¹, D. Selva Kumar ²

Affiliations
1 Department of Pharmaceutical Analysis and Quality Assurance, Nalanda College of Pharmacy, Cherlapally, Nalgonda, Andhra Pradesh, IN
2 School of Pharmacy, Taylors University, Subang Jaya, MY

Abstract

The present method describes simple, sensitive, rapid, accurate, precise and economical Spectrophotometric method for the simultaneous determination of Diclofenac Sodium and Eperisone Hydrochloride in bulk and capsule dosage form. The method is based on the Vierodts Method (simultaneous estimation)for analysis of both the drugs using distilled water as solvent. Diclofenac sodium (DIC) has absorbance maxima at 277 nm and Eperisone hydrochloride (EPE) has absorbance maxima at 255 nm in distilled water. The linearity was obtained in the concentration range of 2- 12 μg/mL and 3-18 μg/mL for Diclofenac Sodium and Eperisone Hydrochloride, respectively. The concentrations of these drugs were determined by using vierodts equations. The mean % recovery (w/w%) was 99.3 and 100.3% for Diclofenac Sodium and Eperisone Hydrochloride, respectively. The proposed method was found to be simple and sensitive for the routine quality control application of dosage form of Diclofenac Sodium and Eperisone Hydrochloride. The results of analysis have been validated statistically according to ICH guidelines.

Keywords

Diclofenac Sodium, Eperisone Hydrochloride, Recovery, Vierodts Method, RAPISONE D SR capsules, Validation, ICH

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