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

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. The X-ray procedure for the identification and...

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Bibliographic Details
Published in:Journal of young pharmacists 2013-12, Vol.5 (4), p.127-132
Main Authors: Kommavarapu, Pavan, Maruthapillai, Arthanareeswari, Allada, Ravikiran, Palanisamy, Kamaraj, Chappa, Praveen
Format: Article
Language:English
Subjects:
Analysis of variance
Crystallinity
Crystallization
Drug product
Original
Regression analysis
Regressions statistics
Statistics
Studies
X-ray powder diffraction
X-rays
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Summary: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. 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. 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. 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.
ISSN:0975-1483
0975-1505
DOI:10.1016/j.jyp.2013.10.003