LITERATURE REVIEW

Literature review
Sinha Manish et al.,(2014) RP-HPLC Method Development And Validation Of Tramadol
Hydrochloride In Bulk Form By Ion-Pair Liquid Chromatography .A simple, selective,
accurate and precise high-performance liquid chromatographic (HPLC) method for
estimation of Tramadol HCl in bulk form was developed & validated. The estimation was
carried out on Phenomenax luna C-18 (250x4.6 mm,5) column using a mobile phase
consisting of 20 mM potassium dihydrogen phosphate, 1.75mM 1-octane sulfonic acid
sodium salt, 2% isopropanol: Methanol (25:75 v/v) of pH 4.0 adjusted with orthophosphoric
acid, at a flow rate 1 ml/min. The UV detection was carried out at 272 nm. Method validation
was performed as per the ICH guidelines. The method was validated for the precision,
accuracy, linearity and robustness.18

Satish A. Patel et al.,(2013) Development and Validation of RP-HPLC Method for

Simultaneous Estimation of Tramadol Hydrochloride and Diclofenac Sodium in Synthetic
Mixture. A simple, accurate, and rapid reversed phase high performance liquid
chromatographic method has been developed and validated for the simultaneous estimation
of Tramadol Hydrochloride (TRM) and Diclofenac sodium (DIC) in synthetic mixture. The
separation was carried out using mobile phase consisting of methanol: phosphate buffer (pH,
6.0) (68:32, v/v). The column used was Phenomenex C18, (250 mm x 4.6 mm i.d., 5 m)
with flow rate 1.2 ml/min using PDA detection at 219 nm. The method was linear over a
concentration range 2 - 30 g/ml for both drugs. The retention time of Tramadol
hydrochloride and Diclofenac sodium were found to be 6.30 min and 8.35 min respectively.
Results of analysis were validated statistically and by recovery studies. The mean recovery
was 99.29 0.54 and 99.03 0.45 for TRM and DIC respectively. The limit of detection
(LOD) and the limit of quantification (LOQ) for TRM and DIC were found to be 0.6586 and
1.9956 g/ml and 0.6169 and 1.8695 g/ml, respectively. The results of the study showed that
the proposed RP-HPLC method was found to be simple, sensitive, precise and accurate and
also useful for the routine determination of TRM and DIC in mixture.19
P.Desai et al.,(2012) Development and Validation of HPTLC Method for Estimation of
Tramadol HCl in Bulk and in Capsule Dosage Form. A new, economic, eco friendly and rapid
high-performance thin-layer chromatographic (HPTLC) method was developed and validated
for quantitative determination of Tramadol HCl. The HPTLC separation was achieved on an
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LITERATURE REVIEW

aluminium-backed layer of silica gel 60F254 using ethyl acetate: methanol: ammonia(25%)
(9.0 : 1.0 :0.5 ml(v/v/v)) as mobile phase. Quantitation was achieved by densitometric
analysis at 271 nm over the concentration range of 1000-6000 ng/spot. The method was
found to give compact spot for the drug (R f 0.76 0.011). The linear regression analysis data
for the calibration plots showed good linear relationship with r2 = 0.9933. The method was
validated for precision, recovery, repeatability, and robustness as per the International
Conference on Harmonization guidelines. The minimum detectable amount was found to be
116.38 ng/spot, whereas the limit of quantitation was found to be 352.67 ng/spot. Statistical
analysis of the data revealed that the method is precise, accurate, reproducible, sensitive and
selective for the analysis of Tramadol HCl. The method was successfully employed for the
estimation of Tramadol HCl as a bulk drug and in capsule dosage form.20

Rajesh M. Kamble et al.,(2012) Stability-Indicating RP-HPLC Method for Analysis of

Paracetamol and Tramadol in a Pharmaceutical Dosage Form. A simple, isocratic, rapid and
accurate reversed phase high performance liquid chromatography method was developed for
the quantitative determination of paracetamol and tramadol in commercial medicinal tablets.
The chromatographic separation was achieved on an Intersil C (250 mm x 4.6 mm, 5m)
column using water pH 3.4 with orthophosphoric acid: methanol (60:40, v/v) as a mobile
phase, and UV detection at 228 nm. The chromatographic resolutions between paracetamol
and tramadol were found greater than five. The linear range for paracetamol and tramadol
were 20.839.0 g/ml and 2.44.5 g/ ml was obtained with correlation coefficients 0.999
for each analyte. The retention time were found to be 2.1 and 3.9 min for tramadol and
paracetamol respectively. Paracetamol and tramadol was subjected to stress conditions
(hydrolysis (acid, base) oxidation, photolysis and thermal degradation) and the stressed
samples were analyzed by use of the method. The major degradation was observed in acid
and minor in base, thermal, oxidation and photolysis. The forced degradation studies prove
the stability indicating power of the method.21

Yalda H. Ardakani et al.,(2007) Improved liquid chromatographic method for the

simultaneous determination of tramadol and its three main metabolites in human plasma,
urine and saliva. Tramadol, an analgesic agent, and its main metabolites Odesmethyltramadol (M1), N-desmethyltramadol (M2) and O,N-didesmethyltramadol (M5)
were determined simultaneously in human plasma, saliva and urine by a rapid and
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LITERATURE REVIEW

specificHPLCmethod. The sample preparationwas a simple, one-step, extraction with ethyl

acetate. Chromatographic separation was achieved with a ChromolithTM Performance RP18e 100mm4.6mm column, using a mixture of methanol:water (19:81, v/v) adjusted to pH
2.5 by phosphoric acid, in an isocratic mode at flow rate of 2 ml/min. Fluorescence detection
(ex 200 nm/em 301 nm) was used. The calibration curves were linear (r2 > 0.996) in the
concentration ranges in plasma, saliva and urine. The lower limit of quantification was 2.5
ng/ml for all compounds. The within- and between-day precisions in the measurement of QC
samples at four tested concentrations were acceptable in all analyzed body fluids The
developed procedure was applied to assess the pharmacokinetics of tramadol and its main
metabolites following administration of 100 mg single oral dose of tramadol to healthy
volunteers.22

Wiwin Farina kartinasari et al.,(2004) HPLC Determination and Validation of Tramadol

Hydrochloride in Capsules. A simple, rapid, and validated HPLC method has been
developed for determination of tramadol hydrochloride in tablet preparations. A
LiChrospher 100 CN column was used with a mobile phase consisting of an acetonitrile
ion pair solution, 25 + 75, v/v. Quantitative evaluation was performed at 275 nm. The
HPLC method is selective, precise, and accurate, and can be used for routine analysis of
the capsule preparations in pharmaceutical industry quality control laboratories.23

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