DESIGN, DEVELOPMENT AND VALIDATION OF AMOXICILLIN AND CLOXACILLIN FORMULATION BY HPLC
Keywords:
Amoxicillin, cloxacillin, stability, HPLC, ValidationAbstract
Background: A simple, rapid and accurate and stability indicating RP-HPLC method was developed for the determination of amoxicillin and cloxacillin in pure and tablet forms. The method was validated with respect to linearity, precision, accuracy, and selectivity. The mean values of slope, intercept and correlation coefficient were 0.9991(r2) respectively. The % COV values for repeatability and intermediate precision studies were < 2 indicates good precision of the method. The recovery of the drug ranged from 99.95-100.72% from a mixture of degradation products. The method was specific to drug and also selective to degradation products. The method showed a linear response for concentrations in the range of 300-1500 ?g/ml using 0.01 M potassium dihydrogen phosphate (pH 5.0) buffer: acetonitrile [15:85] as the mobile phase with detection at 225.0 nm and a flow rate of 5 ml/min and retention time 15-20 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, forced degradation, solution stability and selectivity. Quantitative and recovery studies of the dosage form were also carried out and analyzed; the % RSD from recovery studies was found to be less than 1. Due to simplicity, rapidity and accuracy of the method, we believe that the method will be useful for routine quality control analysis.
Downloads
References
Raveru higuchi, einar brochmann, Pharmaceutical analysis, 1st edition, 1-7.
Willard merrit, Dean settle. Instrumental methods of analysis, 7th edition, 513,625-629.
Holler Skoog. Principles of instrumental analysis, 6th edition, 829-836.
Gary D.Christian.Analytical chemistry, 6th edition, 613.
Kenneth A. Connor’s, a textbook of pharmaceutical analysis, 3rd edition, 392.
David G.watson, Pharmaceutical analysis, 2nd edition, 268-279.
S.singh, B.singh, R.sexana Journal of pharmaceutical biomedical analysis 41(2006)-1037-1040.
A.Mohammadi, I.Haririan, R.B.walker, Journal of chromatography, A 1116(2006), 153-157.
I.Ivala, Z.Ljiljana, Z.mira, Journal of chromatography, A 1119(2006), 209-215.
ICH, Q1.A (R2), Stability testing of new drug substances and products in international conference on harmonization. IFPM, Geneva, 2003.
G.Grosa, E.D.Grosso, G.Allegro Journal of pharmaceutical and biomedical analysis, 41(2006), 798-803.
A.Mishal, D.Sober, Journal of pharmaceutical and biomedical analysis, 39(2005), 819-823.
Gilbert S.banker, Christopher Rhodes, Modern pharmaceutics 3rd edition, volume-72, 179-208.
Sumie Yoshioka, Valentio J.stella, Stability of drugs and dosage forms, 5-24.
John.H.Block, John.M.Beale, Wilson and Giswold’s, textbook of organic medicinal of pharmaceutical chemistry, 11th edition, 311-313.
David A. Williams, Thomas.L.Lemke Foye’s principles of medicinal chemistry, 5th edition, 841.
Joel. G. Hardman, Lee.e.Limbird, Goodman and Gillman’s, the pharmaceutical basis of therapeutics, 10th edition, 1102-1164.
H.P Rang &m.m.Dale,Pharmacology,5th edition, 641.
Jensten Cartensten &T.Rhodes, Drug Stability 3rd edition, volume-107, 516,580-589.
Satindar Abuja &Stephen Scypinski Handbook of modern pharmaceutical analysis, .-09, 95-103.
ICH Q2 (R1), Validation of analytical procedures: Text and methodology, IFPMA, Geneva, 2003.
Klaus Florey, Analytical profiles of drug substances Volume-07, 21-22, and 34-39.
Klaus Flory, Analytical profiles of drug substances, Volume-04, 115,124-126.
Martindale The complete drug reference, 13th edition, 192,149-150.
The Merck index, 13th edition, 582, 2445.
USP (NF)-2003, the official component of standard, Asian edition, 140,498-499.
Indian pharmacopoeia (IP)-1996, Volume-I, 199.
Vijay kumar, Hemant Bhutani, Saranjit Singh, Journal of pharmaceutical &Biomedical analysis, july-06.
K.Raghu Naidu, Udhav N.Kale, Journal of pharmaceutical &biomedical analysis, April-05.
Jalesh Varshosaz, Farid porkoosh, Journal of pharmaceutical &Biomedical analysis, jan-07.
Sunder Natrajan, Bhanu Raman, Indian drugs, Feb-07, vol-44 (295-102.
Shah.D.A, Metha R.S., Bhatt.k.k, Indian drugs, Dec-07, vol-44 (12).
Indian drugs, Volume-43 (5), May-06.
Rao B.M.Srinivasu, M.K. Sridhar, G.Reddy, Indian drugs, volume-41 (1), Jan-06.
Vijaya kumar, M.Muley, Indian drugs, volume-41 (5), May-04.
Kumar R.S., Reddy R.N., Nagraju B. Indian drugs, volume-43 (11), November-06.
P.Perez.Lozano, E.Garcia Montoya, M.Minarro, Journal of pharmaceutical &biomedical analysis, Volume-42, September-06.
ICH Q1A (R2), Stability testing of new drug substances and products.
Published
How to Cite
Issue
Section
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright © Author(s) retain the copyright of this article.