Pharma Focus Asia

Design of experiment based validated stability indicating RP-HPLC method of temozolomide in bulk and pharmaceutical dosage forms

Author: Anam Khana, Syed Sarim Imamb, Mohd Aqila, Yasmin Sultanaa, Asgar Alia, Khalid Khanc

Abstract:

A simple, precise, stability indicating RP-HPLC method was developed and validated for determination of Temozolomide (TMZ) in bulk sample and nanostructured lipid carriers. A Box–Behnken statistical design with three factors and three levels was employed to optimize the chromatographic conditions. The separation was achieved using solvent system combination using methanol: water (30:70) with acetic acid (0.25%). The developed method was validated for linearity, precision, accuracy, limit of detection and limit of quantitation, and robustness in accordance with the ICH guidelines. Further degradation study of TMZ in different stress conditions was studied. The method was found linear with regression co-efficient of 0.999 over a wide range of 10–100 µg/mL. All the validation parameters were found to be within the acceptance range. The developed method was successfully applied to estimate the amount of TMZ in pharmaceutical formulations.

Keywords

Statistical design; Optimization; Temozolomide; Validation; Stability

Citation: Anam Khana, Syed Sarim Imamb, Mohd Aqila, Yasmin Sultanaa, Asgar Alia, Khalid Khanc Design of experiment based validated stability indicating RP-HPLC method of temozolomide in bulk and pharmaceutical dosage forms doi:10.1016/j.bjbas.2015.11.011.

Received: 9 July 2015, Revised: 25 November 2015, Accepted: 28 November 2015, Available online: 8 April 2016

Copyright: © 2016 Beni-Suef University. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Conclusions

Further, the method was optimized by design of experiment optimization technique using different variables. The measured signal was shown to be precise, accurate, and linear over the concentration range tested with a correlation coefficient better than 0.99. Moreover, the lower solvent consumption along with the short analytical run time of 3.8 min leads to a cost effective and environmentally friendly chromatographic procedure. The forced degradation studies showed well separation of parent peak from degradation metabolites. Thus, the above validated method is rapid, selective, specific, and accurate can be used for the separation of impurities and quantitative determination of TMZ in API and pharmaceutical formulations. The method demonstrated high degree of practical utility for estimation of TMZ in pharmaceutical dosage forms.

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