Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Development and Validation of a Stability Indicating RP-HPLC Method for Estimation of Etizolam in Tablet Dosage Form


Affiliations
1 Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, Andhra Pradesh, India
     

   Subscribe/Renew Journal


A simple, precise, and sensitive stability indicating liquid chromatographic method was developed and validated for Etizolam in tablets. An isocratic RP-HPLC method was developed for Etizolam on a C18 Agilent (150 x 4.6 mm x 3.5μm) column using a mobile phase consisting of acetonitrile and triethylamine solution, pH 3.2 (50:50, v/v) at a flow rate of 1.0 mL/min. The chromatographic peaks for Etizolam were eluted at 3.21 ± 0.24 min and the detection was carried out at 254 nm. The method obeyed linearity in the range of 0.5 - 100 μg/mL (r2=0.999). The method gave repeated results as observed from the % RSD (< 2.0) indicating the precision. The mean recovery obtained in the present method was found to be 98.58 ± 0.32%. The drug was subjected to a variety of stress environments and was highly sensitive to acid, base and oxidation conditions. The method was validated as per ICH guidelines in terms of specificity, accuracy, precision, LOD, LOQ and robustness. This method can be used for quantification of Etizolam in tablet dosage form without any interference from excipients.

Keywords

Etizolam, Stability Indicating, RP- HPLC, Isocratic, ICH, Validation.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Maryadele ON, Editor, The Merck Index, an Encyclopedia of Chemicals Drugs and Biologicals, . Merck Research Laboratories, Whitehouse Station, NJ, USA. 2006; 14th ed: 660.

  • Prasenjit M, Ramanarsimha RA, Swarnamanju G, Ramakrishna R. Novel Extractive Colorimetric and UV Spectrophotometric Estimation of Etizolam in Bulk and Tablet by Forming Ion Association Complex with Methyl Orange and Bromocresol Green. Toxicological & Environmental Chemistry. 2015; 97(5): 515-525.

  • Chiragkumar RP, Yural P, Bhumikha S. Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Etizolam in Tablet Dosage Form. Journal of Pharmaceutical Sciences and Bioscientific Research. 2014; 4(4): 270-275.

  • Syama SB. Development and Validation of Liquid Chromatographic Method for Estimation of Escitalopram Oxalate in Tablet Dosage Forms. Int. International Journal of Biological Sciences. 2011; 2(1): 140-146.

  • Divya S, Hasumati R, Neelam P. Development and Validation of Analytical Method for Aripiprazole and Escitalopram Oxalate by Simultaneous Equation Spectroscopic Method. Asian Journal of Pharmaceutical Analysis. 2016; 6(1): 41-46.

  • Kakde RB, Santone DD. Spectrophotometric Method for Simultaneous Estimation of Escitalopram Oxalate and Clonazepam in Tablet Dosage Form. Indian Journal of Pharmaceutical Sciences. 2009; 71(6): 702-705.

  • ICH Harmonized Tripartite Guideline; Validation of Analytical Procedures: Text and Methodology, Q2(R1); International conference on Harmonization, IFPMA, Geneva, Switzerland; 2005.

  • ICH Harmonized Tripartite Guideline; Stability Testing of New Drug Substances and New Drug Products Q1A (R2); International conference on Harmonization, IFPMA, Geneva, Switzerland; 2003.

  • ICH Harmonized Tripartite Guideline; Stability testing: Photo stability testing of new drug substances and products Q1B; International Conference on Harmonization, IFPMA, Geneva, Switzerland; 1996.


Abstract Views: 248

PDF Views: 0




  • Development and Validation of a Stability Indicating RP-HPLC Method for Estimation of Etizolam in Tablet Dosage Form

Abstract Views: 248  |  PDF Views: 0

Authors

Sowjanya Gummadi
Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, Andhra Pradesh, India
Ganapaty Seru
Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, Andhra Pradesh, India
Sree Ganesh Chittajallu
Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, Andhra Pradesh, India

Abstract


A simple, precise, and sensitive stability indicating liquid chromatographic method was developed and validated for Etizolam in tablets. An isocratic RP-HPLC method was developed for Etizolam on a C18 Agilent (150 x 4.6 mm x 3.5μm) column using a mobile phase consisting of acetonitrile and triethylamine solution, pH 3.2 (50:50, v/v) at a flow rate of 1.0 mL/min. The chromatographic peaks for Etizolam were eluted at 3.21 ± 0.24 min and the detection was carried out at 254 nm. The method obeyed linearity in the range of 0.5 - 100 μg/mL (r2=0.999). The method gave repeated results as observed from the % RSD (< 2.0) indicating the precision. The mean recovery obtained in the present method was found to be 98.58 ± 0.32%. The drug was subjected to a variety of stress environments and was highly sensitive to acid, base and oxidation conditions. The method was validated as per ICH guidelines in terms of specificity, accuracy, precision, LOD, LOQ and robustness. This method can be used for quantification of Etizolam in tablet dosage form without any interference from excipients.

Keywords


Etizolam, Stability Indicating, RP- HPLC, Isocratic, ICH, Validation.

References