Journal of Pharmaceutical Research

P. K. Saini ¹, C. L. Jain ², R. M. Singh ¹, S. C. Mathur ¹, G. N. Singh ¹

Affiliations
1 Research and Development Division, Central Indian Pharmacopoeia Laboratory, Indian Pharmacopoeia Commission, Govt. of India, Ministry of Health & FamilyWelfare, Sector-23, Rajnagar, Ghaziabad-201002, IN
2 Department of Chemistry, M. M. H. College, Ghaziabad (U.P.), IN

Abstract

A high-performance liquid chromatographic (HPLC) method has been developed for the determination of Artemisinin in Artemisia annua Herb. The HPLC separation was carried out in isocratic mode using C18, sunfire column (4.6 × 250 mm, 5 μm particle size) with a mobile phase composed of acetonitrile : water (85:15 v/v) at a flow rate of 1.0 ml/min. The detection was monitored at 216 nm. The method validation parameters showed good results for linearity, precision, accuracy, specificity, and in recovery studies. The calibration curve for Artemisinin was found linear from the range of 500 to 1200 μg/ml. The interday and intraday studies (relative standard deviation) was obtained within the limits. The proposed HPLC method is precise, accurate and rapid for determination of Artemisinin in Artemisia annua Herb.

Keywords

Artemisinin, HPLC, Artemisia Annua Herb.

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P. K. Saini ¹, C. L. Jain ², R. M. Singh ¹, S. C. Mathur ¹, G. N. Singh ¹, M. Naslam ³

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

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.

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P. K. Saini ¹, R. M. Singh ¹, C. L. Jain ², S. C. Mathur ¹, G. N. Singh ¹

Affiliations
1 Research and Development Division, Indian Pharmacopoeia Commission, Govt. of India, Ministry of Health & Family Welfare, Sector-23, Rajnagar, Ghaziabad-201002, (U.P.), IN
2 Department of Chemistry, M. M. H. College Ghaziabad-201001, (U.P.), IN

Abstract

A simple, precise, rapid, accurate and economic high performance liquid chromatographic (HPLC) method has been developed for the estimation of Efavirenz in bulk and its tablet dosage forms. A sunfire C₁₈ column was used for the determination of efavirenz using methanol and acetonitrile as mobile phase in the ratio of 7:3 v/v, at ambient temperature and the detector was set at 249 nm. The Linearity of efavirenz was found in the range of 10-400 μg/ml with acceptable value of correlation coefficient 0.9997. The method was validated for accuracy, precision, robustness and recovery studies. The recovery of the drug was found to be 99.89%, relative standard deviation was found to be less than 2% for precession studies and method was found to be robust with the varying condition of flow rate (±10%), wavelength of detection (±5nm), column oven temperature (±5°C). The suitability of the developed HPLC method for quantitative determination of efavirenz 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

Efavirenz, HPLC, Method Development and Validation.

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