Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF GABAPENTIN AND MECOBALAMINE IN BULK AND ITS TABLETS

Sumaiya Hyder* and R. Vani.

ABSTRACT

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the simultaneous estimation of Gabapentin & Mecobalamine from bulk and formulation. Chromatographic separation was achieved isocratically on a Waters C18 column (250x4.6, 5μ particle size) using a mobile phase, 500:500 (OPA: methanol). The flow rate was 0.8 ml/min and effluent was detected at 275 nm and 1 0μl of sample was injected. The run time was found to be 8min. Linearity was observed in the concentration range of 50-150 % for Gabapentin&Mecobalamine. Percent recoveries obtained for both the drugs were 100.00-100.00%. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision, LOD and LOQ. The method developed was successfully applied for the analysis of simultaneous estimation of Gabapentin&Mecobalamine tablets.

Keywords: Gabapentin, Mecobalamine, Methanol, orthophosphoric acid.