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Extensive literature survey reveals that previous studies have reported the
determination of repaglinide employing UV and visible spectrophotomeric,[4-6]
33δ ȱ ǻŗǼ
LOD =
S
33 δ
LOD = ȱ ǻŘǼ
S
5peciſcity
A sample solution of tablet was prepared in the
test concentration range and injected into the
chromatograph, to evaluate possible interfering peaks.
For spectrophotometric analysis the UV spectrum of
this solution was recorded in the range of 200-400 nm Figure 2: UV spectra of repaglinide in methanol
ȱ ȱ ȱ Ŗǯşşşȱ ȱ Ĵȱ ȱ ¢ȱ ȱ Analysis of tablets
the methods. The quantitative results using UV and HPLC methods
ȱ ȱȱȱśǯȱȱ ȱȱ¢ȱęȱ
Precision difference between the mean values, although UV
The precision data obtained for the evaluated ȱ ȱ¢ȱȱƖȱǯǯǯȱȱȱ
methods are demonstrated in Table 2. Both methods with HPLC method. Therefore, both analytical methods,
ȱǯǯǯȱȱ ȱȱŘǯŖƖȱȱȱ were found to be accurate, precise and could be used for
good precision but HPLC method highly precise as routine quality control analysis of repaglinide.
compared to UV method.
Accuracy
CONCLUSIONS
Accuracy was investigated by means of recovery
The advantage of UV method over HPLC method
studies using the developed methods. Both
is that the proposed UV method does not require
spectrophotometric and chromatographic methods
the elaborate treatment and procedures usually
¡ȱ ȱ ȱ ǻn ȱ ƽȱ şǼȱ ȱ ȱ ŗŖŖƖȱ associated with chromatographic method. It is
ǽȱřȱȱŚǾǰȱȱȱȱ¢ǯ less time consuming and economical. A statistical
comparison of the quantitative determination of
Ruggedness
repaglinide shows that HPLC method as more
ȱƖȱǯǯǯȱȱȱ ȱȱȱȱȱ
accurate and precise than UV method. The results
ȱŘƖȱ ȱȱȱȱspectrophotometric
indicate HPLC and UV spectrotometry methods are
and HPLC methods. The results of ruggedness were
adequate methods to quantify repaglinide in pure
ȱȱȱřǯ form and its dosage form. There was no interference
5peciſcity
The chromatogram obtained with the tablet sample Table 1: Result from system suitability study
solution with excipients shows no interfering peaks in Parameters* Repaglinide
the retention time of repaglinide. For the UV method, 5HWHQWLRQWLPHPLQ
no interfering absorption band was found at 241 nm, 7DLOLQJIDFWRU 1.22
7KHRUHWLFDOSODWHV1
in the spectrum of the tablet sample solution.
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ȱ ȱ ȱ ȱ ȱ ȱ ȱ ȱ ŗǯŗśȱΐȦȱ
ȱ řǯŚŞȱ ΐȦǰȱ Ŗǯŝřȱ ΐȦȱ ȱ ŘǯŘŗȱ ΐȦȱ ȱ
spectrophotometric and HPLC methods, respectively. Table 2: Validation parameters of evaluated
methods
Parameters UV HPLC
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Figure 3: Chromatogram of standard solution of repaglinide 6SHFL¿FLW\ 6SHFL¿F 6SHFL¿F
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Table 5: Statistical comparison of results 2. Budavari S, editor. The Merck Index, an encyclopedia of chemicals,
obtained by the proposed methods for the ȱȱǯȱŗřthȱǯȱȱǰȱDZȱȱȱȱ
analysis of repaglinide in tablets DzȱŘŖŖŗǯȱǯȱŝşŖǯ
Drug Label claim Parameter UV HPLC řǯȱ ¢ȱ ǯȱ ǰȱ ȱ ȱ ȱ ǯȱ řřrd ed.
mg/tablet (n = 6) method DZȱȱDzȱŘŖŖŘǯȱǯȱřřŚǯ
5HSDJOLQLGH 2.0 0HDQ 4. Goyal A, Singhvi I. Visible spectrophotometric methods for estimation
of repaglinide in tablet formulation. ȱȱȱȱŘŖŖŜDzśDZŝşȬŞŖǯ
$PRXQWIRXQGPJ
5. Sharma S, Sharma MC. Simultaneous determination of repaglinide
6'
in pharmaceutical dosage form using indigo carmine. Amer Eurasian
56'
ȱȱȱŘŖŗŗDzŜDZŚŝȬśŗǯ
ȗǤǤǣǢǤǤǤǣ Ŝǯȱ ȱ ǰȱ ȱ ǰȱ ȱ
ǯȱ ȱ ȱ
estimation of metformin and repaglinide in a synthetic mixture.
ȱȱȱȱŘŖŖŝDzŜşDZŞŚŚȬśŘǯ
by excipients in the tablets and the mobile phase is ŝǯȱ
ȱǰȱȱǰȱ ¢ȱ
ǯȱȱȱĚȱ
easy to prepare. Since these methods are simple, and HPLC methods for in vitroȱ ¢ȱ ȱ ǯȱ ȱ ȱ
ęǰȱ ǰȱ ȱ ȱ ǰȱ ¢ȱ ¢ȱ ȱ ȱȱŘŖŗŖDzŝŘDZŘŚŖȬŘǯ
8. ȱ ǰȱ ȱ
ǯȱ ȱ ȱ ȱ ȱ
successfully and conveniently adopted for routine
pharmaceutical formulation by HPLC with UV detection. Anal Sci
quality control analysis of repaglinide in bulk and ŘŖŖřDzŗşDZŗŜŝśȬŞŘǯ
pharmaceutical dosage form. şǯȱ ȱǰȱȱǰȱȱǰȱȱǰȱȱǯȱȱ
ȱ ȱ ȱ ȱ ȱ ¢ȱ
ǯȱ Applied
Sci Res ŘŖŖşDzśDZŗśŖŖȬŚǯ
ACKNOWLEDGMENTS ŗŖǯȱ £ ȱ ǰȱ ȱ ǰȱ ȱ ǰȱ ȱ ǰȱ ȱ
ǯȱ ȱ
development and validation of repaglinide in human plasma by
ȱ ȱ ȱ ȱ ȱ ȱ ǯȱ ȱ ȱ
Authors are thankful to the Manager, USV Lab. Pvt. Ltd.,
ȱȱŘŖŖŝDzŚřDZŗŞřŗȬśǯ
ǰȱ ȱ ȱ ȱ ȱ Ğȱ ȱ ȱ ȱ 11.
ȱ ǰȱ Řǰȱ ȱ ȱ ¢ȱ DZȱ
ȱ ȱ ǯȱ
ǯȱ ǯȱ ǰȱ ǰȱ ȱ ȱ ¢ǯȱȱȱȱ
£ǯȱ DZȱ
College of Pharmacy, Nagpur for providing experimental £DzȱŗşşŜǯ
facilities for this work.
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