Journal :   Asian Journal of Research in Chemistry

Volume No. :   7

Issue No. :  4

Year :  2014

Pages :   426-433

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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A new, simple, sensitive, accurate and rapid analytical method development and validation for simultaneous estimation of Pregabalin, Mecobalamin and Alpha Lipoic Acid in bulk as well as in pharmaceutical dosage form by using RP-HPLC



Address:   S. Ashutosh Kumar *1, Manidipa Debnath2, Dr. J. V. L. N. Seshagiri Rao3, D. Gowri Sankar4
1 Department of Pharmaceutical Analysis and Quality Assurance, AKRG College of Pharmacy, Nallajerla, West Godavari, 534112, A.P, India
2Department of Pharmaceutics, AKRG College of Pharmacy, Nallajerla, West Godavari, 534112, A.P, India
3Prof. Pharmaceutical Analysis, Yalamarty College of Pharmacy, Tarluwada Visakhapatnam, 530052, A.P, India
4Department of Pharmaceutical Analysis and Quality Assurance, College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, 530003, A.P
*Corresponding Author
DOI No:

ABSTRACT:
Objective: The present work was undertaken with the aim to develop and validate a rapid and consistent RP-HPLC method in which the peaks will be appear with short period of time as per ICH Guidelines. The proposed method was simple, fast, accurate and precise method for the Quantification of drug in the dosage form, bulk drug as well as for routine analysis in Quality control. Method: RP-HPLC method was developed and validated for simultaneous estimation of Alpha Lipoic Acid, Mecobalamin and Pregabalin in bulk drug and in combined dosage forms. The HPLC separation was achieved on a Symmetry C18 (4.6 x 100mm, 5.0?m, Make: Thermosil) or equivalent in an Isocratic Mode. The mobile phase was composed of Buffer (60%) whose pH was adjusted to 6.0 by using Ortho Phosphoric Acid, Acetonitrile (20%) [HPLC Grade] and Methanol (20%) [HPLC Grade]. The flow rate was monitored at 0.8 ml per min. The wavelength was selected for the detection was 210 nm. The run time was 10min. Conclusion: The retention time found for the drugs Alpha Lipoic Acid, Mecobalamin and Pregabalin were 1.803 min., 2.506 min. and 6.459 min. respectively. The % recovery was found to be 99.8%- 99.8% for the drug Alpha Lipoic Acid. The % recovery was found to be 99.8% - 101.3% for the drug Mecobalamin. The % recovery was found to be 99.8% - 100.87% for the drug Pregabalin. The linearity was established in the range of 50 to 90ppm for the drug Alpha Lipoic Acid and 0.37 to 0.67ppm for the drug Mecobalamin and 37.5 to67.5 ppm for the drug Pregabalin. The LOD for the drugs Alpha Lipoic Acid, Mecobalamin and Pregabalin were found to be 0.504µg/ml, 0.0005µg/ml, and 0.35µg/ml respectively. The LOQ for the drugs Alpha Lipoic Acid, Mecobalamin and Pregabalin were found to be 1.3µg/ml, 0.0052µg/ml and 0.866µg/ml respectively. Conclusion: The proposed method was adequate sensitive, reproducible, and specific for the determination of Alpha Lipoic Acid, Mecobalamin and Pregabalin in bulk as well as in pharmaceutical dosage form. The validation of method was carried out utilizing ICH-guidelines. The described RP-HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form. Overall the proposed method was found to be suitable and accurate for the Quantitative determination of the drug in Tablet dosage form. The method was simple, precise, accurate and sensitive and applicable for the simultaneous determination of Alpha Lipoic Acid, Mecobalamin and Pregabalin in bulk drug and in combined dosage forms.
KEYWORDS:
Alpha Lipoic Acid, Mecobalamin, Pregabalin, ICH Guideline, RP-HPLC, LOD, LOQ.
Cite:
S. Ashutosh Kumar, Manidipa Debnath, J. V. L. N. Seshagiri Rao, D. Gowri Sankar. A new, simple, sensitive, accurate and rapid analytical method development and validation for simultaneous estimation of Pregabalin, Mecobalamin and Alpha Lipoic Acid in bulk as well as in pharmaceutical dosage form by using RP-HPLC. Asian J. Research Chem. 7(4): April 2014; Page 426-433.
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