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A Simple and Sensitive HPTLC Method for Simultaneous Determination of Abacavir Sulphate and Lamivudine in Tablet Dosage Form


Affiliations
1 Research and Development Division, Indian Pharmacopoeia Commission, Govt. of India, Ministry of Health & Family Welfare, Sector-23, Rajnagar, Ghaziabad-201002, India
2 Department of Chemistry, M. M. H. College, Ghaziabad (U.P.), India
3 Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, New Delhi- 110 062, India
 

A simple, sensitive, precise and rapid high performance thin layer chromatographic (HPTLC) method has been developed for the quantitative estimation of abacavir sulphate and lamivudine in tablet dosage form. Abacavir sulphate and lamivudine were chromatographed on silica Gel 60 GF-254 TLC plate. The solvent system selected was methanol:acetone:n-butyl acetate in the ratio of 1:1:2 (v/v/v) and scanning was carried out in the absorbance mode at 284 nm. The spots were found compact for abacavir sulphate with Rf value of 0.58 and for lamivudine with Rf value of 0.35. Linearity of abacavir sulphate and lamivudine were in the range of 240-1200 ng/spot and 120-600 ng/spot, respectively with acceptable value of correlation coefficient. The method was validated for accuracy, precision, robustness and recovery studies. The limit of detection and quantification for abacavir sulphate were obtained 0.691 and 2.093 ng/spot, respectively, while for lamivudine 1.114 and 3.376 ng/spot, respectively. The suitability of this HPTLC method for quantitative determination of abacavir sulphate and lamivudine was proved by validation in accordance with the ICH guidelines. The developed method can be successfully applied in the routine analysis of commercial pharmaceutical tablets.

Keywords

Abacavir Sulphate, Lamivudine, HPTLC, Method Development and Validation.
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  • A Simple and Sensitive HPTLC Method for Simultaneous Determination of Abacavir Sulphate and Lamivudine in Tablet Dosage Form

Abstract Views: 187  |  PDF Views: 75

Authors

P. K. Saini
Research and Development Division, Indian Pharmacopoeia Commission, Govt. of India, Ministry of Health & Family Welfare, Sector-23, Rajnagar, Ghaziabad-201002, India
C. L. Jain
Department of Chemistry, M. M. H. College, Ghaziabad (U.P.), India
R. M. Singh
Research and Development Division, Indian Pharmacopoeia Commission, Govt. of India, Ministry of Health & Family Welfare, Sector-23, Rajnagar, Ghaziabad-201002, India
S. C. Mathur
Research and Development Division, Indian Pharmacopoeia Commission, Govt. of India, Ministry of Health & Family Welfare, Sector-23, Rajnagar, Ghaziabad-201002, India
G. N. Singh
Research and Development Division, Indian Pharmacopoeia Commission, Govt. of India, Ministry of Health & Family Welfare, Sector-23, Rajnagar, Ghaziabad-201002, India
M. Naslam
Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, New Delhi- 110 062, India

Abstract


A simple, sensitive, precise and rapid high performance thin layer chromatographic (HPTLC) method has been developed for the quantitative estimation of abacavir sulphate and lamivudine in tablet dosage form. Abacavir sulphate and lamivudine were chromatographed on silica Gel 60 GF-254 TLC plate. The solvent system selected was methanol:acetone:n-butyl acetate in the ratio of 1:1:2 (v/v/v) and scanning was carried out in the absorbance mode at 284 nm. The spots were found compact for abacavir sulphate with Rf value of 0.58 and for lamivudine with Rf value of 0.35. Linearity of abacavir sulphate and lamivudine were in the range of 240-1200 ng/spot and 120-600 ng/spot, respectively with acceptable value of correlation coefficient. The method was validated for accuracy, precision, robustness and recovery studies. The limit of detection and quantification for abacavir sulphate were obtained 0.691 and 2.093 ng/spot, respectively, while for lamivudine 1.114 and 3.376 ng/spot, respectively. The suitability of this HPTLC method for quantitative determination of abacavir sulphate and lamivudine was proved by validation in accordance with the ICH guidelines. The developed method can be successfully applied in the routine analysis of commercial pharmaceutical tablets.

Keywords


Abacavir Sulphate, Lamivudine, HPTLC, Method Development and Validation.