Abstract

Narayan Shrivas^1* and S. K. Mishra ²

DOI : http://dx.doi.org/10.13005/ojc/370418

Using RP-HPLC, an accurate and precise technique for the measurement of Temozolomide in its pharmaceutical dose form was developed and validated. Chromatographic separation was achieved on an X Terra RP 18(250mm x 4.6mm), 5 µ column using a mobile phase consisting of methanol and buffer in the ratio of 10:990v/v. The flow rate was 1mL/min with the detection wavelength of 254 nm and retention time was found to be 20 min. The developed method was validated according to ICH guidelines. With a correlation coefficient of 0.9990, linearity was observed in the range of 50-150 percent. The %RSD of the developed method for method precision and Intermediate precision was found to be 0.65 % and 0.59 % respectively. With a percent recovery of 99.82 ±0.045, the approach was confirmed to be reliable. All of the validation parameters yielded results that were within acceptable limits. It was discovered that the procedure was accurate, exact, specific, rugged, and durable. As a result, the newly discovered approach can be used for finish product of quality control and stability testing on a regular basis and it has been confirmed to be stable for Temozolomide is available in both pure and pharmaceutical dose forms.

Method Development; Method Stability Indicating; RP-HPLC; Temozolomide Capsules; Validation

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