Asian Journal of Research in Chemistry

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Validated HPTLC Method for Determination of Repaglinide in Bulk and Tablet Dosage Form


Affiliations
1 Department of Pharmaceutical Chemistry, J. L. Chaturvedi College of Pharmacy, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur-440016, Maharashtra, India
2 University Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur- 440033, Maharashtra, India
3 Department of Pharmaceutical Chemistry, Sharad Pawar College of Pharmacy, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur-441110, Maharashtra, India
     

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A simple, rapid, accurate and precise high performance thin layer chromatographic (HPTLC) method has been developed and validated for the estimation of the repaglinide as bulk and in tablet dosage form. The method employed TLC precoated silica gel 60 F254 aluminium plates as the stationary phase. The solvent system consisted of methanol: chloroform: toluene: triethylamine (5:3:2:0.1 v/v/v/v). The detection of spots was carried out densitometrically using a UV detector at 241 nm in absorbance mode. This system was found to give compact spot for repaglinide with (Rf value of 0.45 ± 0.08). The method was validated in terms of linearity, accuracy, precision, limit of detection, limit of quantification and specificity as per ICH guidelines. The calibration curve was found to be linear over the concentration range of 100-500 ng/spot for repaglinide with significantly high value of correlation coefficient (r2 > 0.99). The limits of detection and quantitation were found to be 20 ng/spot and 90 ng/spot, respectively for repaglinide. The % assay was found to be 99.14 ± 0.34(SD). Accuracy of the method was accessed by percentage recovery and mean % value was found to be 99.51±0.74. The proposed method was found to be accurate, precise, reproducible and specific and can be successfully applicable for the quality control analysis of repaglinide as in bulk drug and pharmaceutical formulations.

Keywords

Repaglinide, High-performance thin layer chromatography (HPTLC), Method Validation
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  • Validated HPTLC Method for Determination of Repaglinide in Bulk and Tablet Dosage Form

Abstract Views: 322  |  PDF Views: 2

Authors

Seema M. Dhole
Department of Pharmaceutical Chemistry, J. L. Chaturvedi College of Pharmacy, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur-440016, Maharashtra, India
Pramod B. Khedekar
University Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur- 440033, Maharashtra, India
Nikhil D. Amnerkar
Department of Pharmaceutical Chemistry, Sharad Pawar College of Pharmacy, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur-441110, Maharashtra, India

Abstract


A simple, rapid, accurate and precise high performance thin layer chromatographic (HPTLC) method has been developed and validated for the estimation of the repaglinide as bulk and in tablet dosage form. The method employed TLC precoated silica gel 60 F254 aluminium plates as the stationary phase. The solvent system consisted of methanol: chloroform: toluene: triethylamine (5:3:2:0.1 v/v/v/v). The detection of spots was carried out densitometrically using a UV detector at 241 nm in absorbance mode. This system was found to give compact spot for repaglinide with (Rf value of 0.45 ± 0.08). The method was validated in terms of linearity, accuracy, precision, limit of detection, limit of quantification and specificity as per ICH guidelines. The calibration curve was found to be linear over the concentration range of 100-500 ng/spot for repaglinide with significantly high value of correlation coefficient (r2 > 0.99). The limits of detection and quantitation were found to be 20 ng/spot and 90 ng/spot, respectively for repaglinide. The % assay was found to be 99.14 ± 0.34(SD). Accuracy of the method was accessed by percentage recovery and mean % value was found to be 99.51±0.74. The proposed method was found to be accurate, precise, reproducible and specific and can be successfully applicable for the quality control analysis of repaglinide as in bulk drug and pharmaceutical formulations.

Keywords


Repaglinide, High-performance thin layer chromatography (HPTLC), Method Validation

References