DEVELOPMENT AND VALIDATION OF REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHYMETHOD FOR SIMULTANEOUS ESTIMATION OF BETAHISTINE DIHYDROCHLORIDE AND PROCHLORPERAZINE MALEATE IN TABLET DOSAGE FORM

Authors

  • PATEL VISHVAS D Department of Quality Assurance, S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Ganpat Vidyanagar, Mehsana, Gujarat, India.
  • PATEL PARESH U Department of Quality Assurance, S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Ganpat Vidyanagar, Mehsana, Gujarat, India.

Keywords:

Betahistine Dihydrochloride, Prochlorperazine Maleate, RP-HPLC, Tablet dosage form

Abstract

This research manuscript describes simple, sensitive, precise, accurate, economic reverse phase high performanceliquid chromatography method for the simultaneous determination of Betahistine Dihydrochloride (BET) and Prochlorperazine Maleate (PRO) in Tablet dosage form. The sample was analyzed by reverse phase C18 column ( X terra C18, 150 mm × 4.6 mm, 5?m) asstationary phase; acetonitrile : methanol : phosphate buffer PH 4 (45 : 45 : 10 , v/v/v) as a mobile phase at a flow rate of 0.8 ml/min. Quantification was achieved with Photo Diode Array detector at 254 nm. The retention time for Betahistine Dihydrochloride was found to be 3.3 min and for Prochlorperazine Maleate was found to be 7.6 min. The linearity was obtained in theconcentration range of 2-30 ?g/ml and 2-30 ?g/ml for BET and PRO respectively. The method was successfully applied in analysis of tablet dosage form because no chromatographic interferences from formulation excipients were found. The method retained its accuracy and precision when the standard addition technique was applied.

Downloads

Download data is not yet available.

References

Maryadele J O’ Neil ed, Merck Index, 14th Edition, Merck & Co. Inc, White House Station NJ: 2005.1177.

U. S. Pharmacopoeia/ NF Vol. II. The United states pharmacopeial convention, Twinbrook pathway Rockvillae, 2013.2635.

Indian Pharmacopoeia. Vol. II. The Controller of Publication. 6th edition. Govt. of India. New Delhi, 2010.897-898.

British Pharmacopoeia. Vol. I. Stationary office. London Medicines and Healthcare product regulatory agency, 2010. 254-255.

European Pharmacopoeia 6.0. Vol. II. 6th edition. Starboary: Council of Europe, 2008.1292.

Ensafi A., Doozandeh F., AllafchianA.,Potentiometric Sensor for Betahistine Determination in Pharmaceuticals, Urine and Blood Serum, J. Braz. Chem. Soc., 2010;21(12):2446-2453.

Kumar A., ChomwalR.,Nanda S., Spectrophotometric estimation of Betahistine hydrochloride in tablet formulations, J Pharm Bio all Sci 2010;2:121-123.

Khedr A., Mahmoud S., Stress degradation studies on Betahistine and development of a validated stability-indicating assay method, Journal of Chromatography B, 2008; 869: 111–117.

Jain R., Yadav R., Voltammetric assay of anti-vertigo drug Betahistine hydrochloride in sodium lauryl sulphate, Colloids and Surfaces A: Physicochem. Eng. Aspects 2010; 366; 63–67.

Indian Pharmacopoeia. Vol. II. The Controller of Publication. 6th edition. Govt. of India. New Delhi, 2010.1972.

Japanese Pharmacopoeia. 15th edition, Shibuya Tokyo Japan; Society of Japanese Pharmacopeia; 2006.1033.

U. S. Pharmacopoeia/ NF Vol. II. The United states pharmacopeial convention, Twinbrook pathway Rockvillae, 2013.4912.

British Pharmacopoeia. Vol. II. Stationary office. London Medicines and Healthcare product regulatory agency, 2010.1769.

European Pharmacopoeia 6.0. Vol. II. 6th edition. Starboary: Council of Europe, 2008.2756.

Aman T., Majeed Z., Kazi A., KhanI., Spectrophometric determination of Prochlorperazine Maleate in Pure and pharmaceutical preparation, MikrochimicaActa, 2002;138: 13-17.

Venkatesh D., Sundaram S., Meyyanathan S.,Muralidharan S., Shanmugam R., Kannan E., Bhojraj S., and Santhi S., Bioavailability Studies on Developed Prochlorperazine Maleate Sustained Release Tablets by HPLC, Journal of Bioanalysis& Biomedicine, 2009;1: 54-59.

Bhagwat G. B., Wate S. P. and Mundhey A. S., Development and Validation of UV Spectrophotometric Method for Estimation of Prochlorperazine Maleate and Pyridoxine Hydrochloride in Tablet Dosage Form by UV Using Multi-Component Mode of Analysis,2013; 3:20-25.

Bhosale D., Nikalje A., Development and validation of RP-chromatography for simultaneous determination of paracetamol, caffeine, ergotamine and Prochlorperazine in tablets, Asian Journal of Pharmaceutical Sciences,2013; 7 (5): 364-370.

ICH, Q2(R1) Validation of Analytical Procedure:Text and Methodology, International Conference on Harmonization, IFPMA, Geneva, Switzerland.[Cited 2013 Feb 5], Available from:www.ich.org/fileadmin/Public.../ICH.../Q2_R1__Guideline.pdf

Published

2014-04-22
Statistics
39 Views | 9 Downloads
Citatons

How to Cite

PATEL VISHVAS D, and PATEL PARESH U. “DEVELOPMENT AND VALIDATION OF REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHYMETHOD FOR SIMULTANEOUS ESTIMATION OF BETAHISTINE DIHYDROCHLORIDE AND PROCHLORPERAZINE MALEATE IN TABLET DOSAGE FORM”. International Journal of Pharmaceutics and Drug Analysis, vol. 2, no. 4, Apr. 2014, pp. 369-74, https://ijpda.com/index.php/journal/article/view/53.

Issue

Section

Research Articles
Share |