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Gummadi, Sowjanya
- Development and Validation of a Stability Indicating RP-HPLC Method for Estimation of Etizolam in Tablet Dosage Form
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Authors
Affiliations
1 Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, Andhra Pradesh, IN
1 Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, Andhra Pradesh, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 4 (2019), Pagination: 1637-1642Abstract
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
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- 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.
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- Development and Validation of Rp-hplc Method for the Determination of Ropinirole Hydrochloride in Bulk and Pharmaceutical Dosage Forms
Abstract Views :148 |
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Authors
Affiliations
1 Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam - 530045, Andhra Pradesh, IN
1 Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam - 530045, Andhra Pradesh, IN
Source
Research Journal of Pharmacy and Technology, Vol 15, No 4 (2022), Pagination: 1761-1767Abstract
A simple, precise, rapid and accurate RP-HPLC method was developed for the estimation of Ropinirole hydrochloride in pure and pharmaceutical dosage forms. The method employed a Phenomenex C8 column (250 × 4.6mm, 5μm) and a mobile phase consisting of 0.1% orthophosphoric acid (pH 2.61) and methanol in the ratio of 50:50 v/v. The flow rate was optimized at 1.2mL/min and the effluents were monitored at 248 nm over a run time of 10.0 min. where the analyte showed the retention at 2.91±0.26 min. The detector response was linear in the concentration of 1-100μg/mL (y = 40236x – 10950). The limit of detection and limit of quantification were found to be 0.0007μg/mL and 0.0021μg/mL respectively. The method was validated as per ICH guidelines and was found to be sensitive, accurate, precise and robust while satisfying all the system suitability. The method was also tested for its stability indicating capability by performing the forced degradation studies and the drug was almost stable in all the exposed conditions with very minor degradations observed. The developed method was used for the assay of the drug in marketed tablets and the percentage assay was found to be 99.32±0.83 %w/w. The results of the study depict that the proposed RP-HPLC method is specific and sensitive for the routine analysis of Ropinirole hydrochloride in bulk drug and in its pharmaceutical dosage form.Keywords
Ropinirole hydrochloride, RP-HPLC, Validation, Stability indicating, ICH.References
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- Sreekanth N, Babu Rao CH, Mukkantu K. RP-HPLC method development and validation of Ropinirole hydrochloride in bulk and pharmaceutical dosage forms. International Journal of Pharmacy and Pharmaceutical Sciences. 2009; 1(1): 186-192.
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- 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.