DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF GABAPENTIN AND NORTRYPTILINE IN PHARMACEUTICAL DOSAGE FORM
Journal Title: Int J of Pharm Res & Analy - Year 2015, Vol 5, Issue 1
Abstract
A simple, precise, rapid, specific and accurate stability indicating reverse phase high performance liquid chromatography method was developed for simultaneous estimation of Gabapentin (GPT) and Nortriptyline (NTL) in pharmaceutical tablet dosage form. Chromatographic separation was performed on Agilent C8, (150 X 4.6mm, 5μm)column, with mobile phase comprising of mixture of buffer: (0.1M ammonium acetate) and methanol in the ratio of 80:20v/v, at the flow rate 1.0 ml/min. The detection was carried out at 254 nm. The retention times of GPT and NTL were found to be 2.66 and 3.58 mins respectively with a run time of 6 mins, theoretical levels for GPT and NTL were 8734 and 8648 respectively, with a resolution of 6.56. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of detection and limit of quantitation, robustness and ruggedness. Linearity of GPT was found in the range of 800-2400 μg/mL and that for CPG was found to be 20-60 μg/mL. The correlation coefficient for GPT and NTL were 0.999 and 1.000 respectively. The LOD values for GPT and NTL were 2.936 and 2.927 μg/mL respectively. The LOQ values for GPT and NTL were and 9.786 and 9.756 μg/mL respectively. This demonstrates that the developed method is simple, precise, rapid, selective, accurate and reproducible for simultaneous estimation of GPT and NTL tablet dosage form
Authors and Affiliations
M. NaveenKumar* , D. SaiMalakondaiah , G. Usha Sree , A. Ajitha , V. Uma Maheshwara Rao
Keywords
Related Articles
- EP ID EP148787
- DOI -
- Views 136
- Downloads 0
DEVELOPMENT OF A STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TRIMETHOPRIM, SULFAMETHOXAZOLE AND METYHL PARABEN IN ORAL SUSPENSION
A gradient Simultaneous estimation by RP-HPLC Method were developed and validated for the quantification of Trimethoprim, Sulfamethoxazole and methyl paraben at single wavelength (275nm) in order to assess assay an...
RECENT APPROCHES FOR IMPURITY PROFILING IN PHARMACEUTICAL FORMULATIONS
In the pharmaceutical world, an impurity is considered as any other organic material, besides the drug substance, or ingredients, arise out of synthesis or unwanted chemicals that remains with API’s. The impurity m...
COMPARATIVE ACCOUNT OF MEDICINAL PROPERTIES OF Andrographis paniculata AND Costus igneus
Both the plants, A. paniculata and C. igneus are easily grown in the kitchen garden of the back yard. Their phenolic contents are responsible for their antioxidant properties. The present paper has been undertaken to co...
FORMULATION AND EVALUATION OF FLOATING DRUG DELIVERY SYSTEM OF ZIDOVUDINE
Zidovudine is considered a good candidate for incorporation in a gastro-retentive dosage form due to its high solubility in the stomach medium compared with its solubility in the small intestine medium. As its solubility...
PHYTOTOXICITY ANALYSIS OF DIFFERENT CARPET DYES AND THEIR FUNGAL EXTRACTED METABOLITES (FUNGAL DEGRADED PRODUCTS) THROUGH RELATIVE SEED GERMINATION AND SEEDLING GROWTH PARAMETERS
To assess the phytotoxicity of five different carpet dyes viz. Methyl Red, Methyl Orange, Erichrome Black, Crystal Violet and Malachite Green and their extracted metabolites, (degraded products) an experiment was s...