Академический Документы
Профессиональный Документы
Культура Документы
com
A simple and sensitive spectrophotometric method has been developed and validated for the estimation of metformin
hydrochloride in bulk and in tablet formulation. The primary amino group of metformin hydrochloride reacts with
ninhydrin in alkaline medium to form a violet colour chromogen, which is determined spectrophotometrically at
570 nm. It obeyed Beer’s law in the range of 8-18 μg/ml. Percentage recovery of the drug for the proposed method
ranged from 97-100% indicating no interference of the tablet excipients. The proposed method was found to be
accurate and precise for routine estimation of metformin hydrochloride in bulk and from tablet dosage forms.
Metformin hydrochloride, chemically 1, get concentration of 100 μg/ml. Twenty tablets were
1-dimethylbiguanide hydrochloride[1] (C4H11N5.HCl) weighed, powdered and the powder equivalent to
is white crystalline powder, hygroscopic and freely 100 mg of metformin hydrochloride was accurately
soluble in water, used as a hypoglycemic drug [2]. weighed, dissolved in 100 ml of distilled water,
Literature survey reveals that only few methods like filtered through Whatmann filter paper No: 41 and
HPLC and GC have been reported for estimation diluted further to get a concentration of 100 μg/ml.
of the metformin hydrochloride in pharmaceutical
formulations and biological fluids [3-9] . Official To a series of (S1, S2, S3, S4, S5) 25 ml volumetric
method includes UV spectrophotometric method for flasks, aliquots of 2.0 to 4.5 ml of the standard
estimation of the drug from the tablets[1]. However no solution of metformin hydrochloride, 1.5 ml of
colorimetric methods are reported for estimation of 5M NaOH, 2.2 ml of 1% ninhydrin solution and
metformin hydrochloride in bulk and in formulations. 10 ml of water was added, heated on a water bath
for 30 min, cooled and volume adjusted to 25 ml
The present work describes a new simple
with water and the absorbance of the solution in
spectrophotometric method based on the reaction
each flask was measured at 570 nm against reagent
between amino group of metformin hydrochloride
blank. The absorbance of sample solution was also
with ninhydrin to form a violet colored complex,
measured and the amount of metformin hydrochloride
which shows absorption maxima at 570 nm.
present in tablet formulation was determined by
The reference standard of metformin hydrochloride was extrapolating from the calibration curve. The results
procured as gift sample from Micro Labs, Bangalore are shown in the Table 1. In order to ascertain the
and tablets (Obimet 500 mg, Kare Labs Pvt. Ltd. suitability and reproducibility of the proposed method,
Goa) were utilized for the study. Ninhydrin and all recovery studies were carried out by adding known
other chemicals, solvents utilized were of AR grade. A quantities of standard metformin hydrochloride to the
double beam spectrophotometer (Shimadzu-UV-1601) previously analyzed sample and the mixtures were
was employed for measurement of absorbance. reanalyzed by the proposed method. The results are
shown in the Table 2. The percentage recovery of
A standard solution of metformin hydrochloride was metformin hydrochloride was found in the range of
prepared by dissolving 100 mg of the drug in 100 ml 97-100% indicating that there is no interference by
of distilled water and further diluted with water to the excipients in the method.
A new, simple, precise, rapid and accurate RP-HPLC method has been developed for the simultaneous estimation
of cefpodoxime proxetil and clavulanic acid from pharmaceutical dosage forms. The method was carried out on
a Zorbax Eclipse XDB 5 µ C 18 (150×4.6 mm) column with a mobile phase consisting of acetonitrile:50 mM
potassium dihydrogen phosphate buffer (pH 3.0, 70:30 v/v) at a flow rate of 1.0 ml/min. Detection was carried out
at 228 nm. Aspirin was used as an internal standard. The retention time of clavulanic acid, cefpodoxime proxetil
and aspirin was 4.43, 6.44 and 5.6 min, respectively. The developed method was validated in terms of accuracy,
precision, linearity, limit of detection, limit of quantification and solution stability. The proposed method can be
used for the estimation of these drugs in combined dosage forms.