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DEVELOPMENT AND VALIDATION OF BIOANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF ETAMSYLATE AND MEFENAMIC ACID IN HUMAN PLASMA BY RP-HPLC METHOD
Mona Karia*1, Bhargav Gohel2, Bina Thanki3, Darshan Madiya4, Shital Faldu5
1,3M.Pharm, Smt. R.D.Gardi B.Pharmacy College. Rajkot, Gujarat, India
2Q.A. Officer, Intas Pharmaceutical Ltd., Ahemdabad.
4Assistant Professor of Smt. R.D.Gardi B.Pharmacy College, Rajkot
5Principal of Smt. R.D.Gardi B.Pharmacy College, Rajkot
An accurate, simple, precise and sensitive HPLC method with UV detection was developed and validated for simultaneous estimation of Etamsylate and Mefenamic acid in human plasma as per USFDA guidelines. Etamsylate and Mefenamic acid were spiked with human plasma and 5 % w/v Trichloro acetic acid used for protein precipitation in ration of 1:9 %v/v of human plasma. The column used was SUSEIDO C18 column (250mm x 25 mm, i.d, 5 µ). Analysis was carried out with Methanol: ACN (70:30 % v/v): Buffer (0.05M Ammonium acetate buffer) pH 6.0 (85:15,% v/v) as mobile phase at flow rate of 1.5 ml/min at 298 nm with UV detection. The retention time of Mefenamic acid observed was 1.98 min and for Etamsylate 3.85 min respectively. The method was validated over the range of 0.5-30 μg/ml for Etamsylate and 0.2-18 µg/ml for Mefenamic acid with coefficients of regression 0.9939 and 0.9914 for Etamsylate and Mefenamic acid respectively. LOD and LOQ were 0.17 ng/ml and 0.51 ng/ml for Etamsylate and 2.62 ng/ml and 7.95 ng/ml for Mefenamic acid.The mean % recovery for MEF and ETM were found to be 89.07% and 88.98%with % C.V. of 1.87% and 1.91% respectively. Inter-day as well intra-day replicate, gave % RSD below 4.44 and 2.63 for Etamsylate and 3.20 and 3.75 for Mefenamic acid respectively. This RP-HPLC method is sensitive, selective, accurate, precise and rapid for the simultaneous estimation of Etamsylate and Mefenamic acid in human plasma with limit of Quantification in nano-gram level was developed and validated as per USFDA guideline and can be applied for a bioequivalence study to compare relative bioavailability of drug.
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SAL Institute of Pharmacy (SALIP) situated in SAL Education campus was established in June-2009 under the aegis of Adarsh Foundation with a view of educating and training young talented students of Gujarat at the field of Pharmacy. It is a self-financed institute approved by All India Council for Technical Education (AICTE), New Delhi, the Government of Gujarat and afileted by Gujarat Technological University.
Soranus Lifesciences is an innovative leading, vertically integrated pharmaceutical formulation company that discovers, develops, manufactures and markets a broad range of healthcare products. Headquartered in the city of Ahmedabad in India, The Company has dedicated research and development department well equipped with the latest equipments and supported by a large pool, of scientists who continuously work towards new pharma products. Soranus Lifesciences Reminisces the Soranus of 1st and 2nd century.
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This Institute started as “Occupational Health Research Institute” (OHRI) in the year 1966 and was re-christened as “National Institute of Occupational Health” (NIOH) in 1970 presently located in the Eastern part of Ahmedabad. Two Regional Occupational Health Centers (ROHCs) were started at Bangalore in 1977 and at Kolkata in 1980.
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