Development of Analytical Profile of Lamotrigine and its API Formulation
DOI:
https://doi.org/10.22159/ajpcr.2022.v15i1.43396Keywords:
Lamotrigine,, UV/Vis spectrophotometer, BMR,, MBTH,HPLCAbstract
Objective: The objective of this review is to put a light on the development of lamotrigine and its active pharmaceutical ingredients formulation with proper demonstration.
Method: In the present work, one of the most imperative spectrophotometric method which is RP-HPLC method has been developed for the quantitative estimation of lamotrigine in bulk and pharmaceutical formulations.
UV spectrophotometric method which involves the determination of Lamotrigine in bulk and in bulk drug and pharmaceutical formulation has maximum absorption at 307.5nm in methanol. It obeys Beer’s and Lambert’s law in the concentration range of 5-45 µg/ml.
A rapid and sensitive RP- HPLC Method with UV detection (270 nm) for routine analysis of Lamotrigine formulation was developed. Chromatography was performed with mobile phase containing a mixture of methanol and Phosphate buffer (65:35v/v) with flow rate 1.0 ml/min. In the range of 20-100 µg/ml, the linearity of lamotrigine shows a correlation co-efficient of 0.9998. The proposed method was validated by determining sensitivity and system suitability parameters.
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References
Sood A, Panchagnula R. Design of controlled release delivery systems using a modified pharmacokinetic approach: A case study for drugs having a short elimination half-life and a narrow therapeutic index. Int J Pharma 2003;261:27-41.
Agoram B, Woltosz BWS, Bolger MB. Predicting the impact of physiological and biochemical processes oral drug bioavailability. Adv Drug Deliv Rev 2001;50:41-67.
Bravo SA, Lamas MC, Salamon CJ. In-vitro studies of diclofenac sodium controlled-release from bio-polymeric hydrophilic matrices. J Pharm Pharma Sci 2002;5:213-9.
Basak SC, Jayakumar RB, Lucas MK. Formulation and release behavior of sustained-release Ambroxol hydrochloride HPMC matrix tablet. Indian J Pharm Sci 2006;68:594-7.
Dandagi, PM, Mastiholimat VS, Patil MB, Manvi FV, Gagad AP, Sharma R. Development and evaluation of theophylline and salbutamol sulphate sustained release matrix tablets. Indian J Pharm Sci 2005;67:598-602.
Arthur HK. Handbook of Pharmaceutical Excipients. 3rd ed. London: American Pharmaceutical Association; 2000. p. 463-4.
Mladena L, Ana P, Svetlene GK, Ksenija GB. Comparison of dissolution profiles and serum concentrations of two lamotrigine tablet formulations. Drugs in R D 2011;11:53-60.
Available from: http://en.wikipedia.org/wiki/Lamotrigine
Available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ index.cfm?fuseaction=Search.drugdetails
Available from: http://www.accessdata.fda.gov/drugsatfda_docs/ label/2006/020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf
The Science and Practice of Pharmacy, Remington part-I. 20th ed. Philadelphia, PA: College of Pharmacy and Science; 2000. p. 558.
Kharia AA, Hiremath SN, Singhai AK, Omray LK, Jain SK. Design and optimization of floating drug delivery system of acyclovir. Indian J Pharm Sci 2010;72:599-606.
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