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Simultaneous estimation of degree of crystallinity in combination drug product of abacavir, lamivudine and neverapine using X-ray powder diffraction technique

1★, 1, 1, 1, 1★ Corresponding author

  1. 1Department of Chemistry, SRM University, Kattankulathur 603203, Tamil Nadu, INDIA.

CORRESPONDENCE

Pavan Kommavarapu

Department of Chemistry, SRM University, Kattankulathur 603203, Tamil Nadu, INDIA.

kommavarapu.pavan@gmail.com

Received: 19-08-2013; Revised: 18-10-2013; Accepted: 17-11-2013.

Volume 5, Issue 4 · pp. 127-132 · 2013 · DOI: 10.1016/j.jyp.2013.10.003

ABSTRACT

Objective: In the present study, simultaneous determination of degree of crystallinity content in abacavir (ABC), lamivudine (3TC) and neverapine (NVP) from there combination drug product using X-ray powder diffraction (XRPD) technique is developed and validated.Methods: The X-ray procedure for the identification and determination of the degree of crystallinity in ABC, 3TC and NVP drug product is developed and validated. It is based on the X-ray diffraction from crystalline region of the drug product. The characteristic peaks of the three drugs were characterized using XRPD.Results: ABC, 3TC and NVP concentrations ranging from 70% to 130% in drug product were prepared and linearity in this concentration range is described. The % coefficient of variation (%CV) was found to be 0.9982 for ABC, 0.9978 for 3TC and 0.9984 for NVP. The mean recoveries were found to be 100.3% for ABC, 99.0% for 3TC and 100.8% for NVP. Regressions statistics and Analysis of variance (ANOVA) table results were evaluated and found to be satisfactory.Conclusions: The method has been applied to unknown mixtures of drug formulations and stability samples. The proposed method can be useful in the quality control of combination drug products.

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    Kommavarapu, P., Maruthapillai, A., Allada, R., Palanisamy, K., & Chappa, P. (2013). Simultaneous estimation of degree of crystallinity in combination drug product of abacavir, lamivudine and neverapine using X-ray powder diffraction technique. Journal of Young Pharmacists, 5(4), 127-132. https://doi.org/10.1016/j.jyp.2013.10.003

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    © 2013 Author(s)

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