Development and validation of the UV-spectrophotometric method for determination of terbinafine hydrochloride in bulk and in formulation

Jain, Pritam S.; Chaudhari, Amar; Patel, Stuti A.; Patel, Z. N.; Patel, Dhwani T.

doi:10.4103/2229-4708.90364

Cited by 51 publications

(39 citation statements)

References 7 publications

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“…The results obtained were used to calculate the equation of the line by using linear regression by the leastsquares regression method [16].…”

Section: Validation Of Methods Linearitymentioning

confidence: 99%

Development and Validation of Uv-Spectrophotometric Methods for Determination of Gemcitabine Hydrochloride in Bulk and Polymeric Nanoparticles

Kaur

2017

Int J App Pharm

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Objective: The objective of the present work was to develop and validate a novel, specific, precise and reliable method for estimation of gemcitabine hydrochloride in bulk and polymeric nanoparticles using UV-visible spectroscopy method. Methods:The UV-Visible spectrophotometric determination was performed with double beam Systronics UV-visible spectrophotometer; model UV-2201 (India). The proposed methods were validated for various parameters like linearity, precision, accuracy, robustness, ruggedness, detection, quantification limits, and formulation analysis as per international conference on harmonization (ICH) guidelines. Results:The method was based on measurement of absorbance at wavelength maxima i.e. 267.2 nm, λmax of the drug in distilled water, phosphate buffer pH 6.8 and 7.4. The method obeyed Beer Lambert's law in the concentration range of 5-30 µg/ml andR 2 -value was found to be 0.999. Moreover, the % drug recovered from polymeric nanoparticles was found to be 97.97%. Conclusion:According to results, the currently developed method shows compliance with acceptance criteria with Q2 (R1) and international conference on harmonization (2005) guidelines, because the % RSD was found to be less than 2%. The developed method was simple, accurate and précised.

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“…The results obtained were used to calculate the equation of the line by using linear regression by the leastsquares regression method [16].…”

Section: Validation Of Methods Linearitymentioning

confidence: 99%

Development and Validation of Uv-Spectrophotometric Methods for Determination of Gemcitabine Hydrochloride in Bulk and Polymeric Nanoparticles

Kaur

2017

Int J App Pharm

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“…From the resulting absorbance, the standard deviation and relative standard deviation were calculated [30].…”

Section: Repeatabilitymentioning

confidence: 99%

“…The ruggedness of the proposed method was determined for 20 μg/ml concentration of HQ by analysis of aliquots from a homogenous slot by two analysts using same operational and environmental conditions [30].…”

Section: Ruggednessmentioning

confidence: 99%

Development and Validation of Uv-Spectrophotometric Method for Estimation of Hydroquinone in Bulk, Marketed Cream and Preapared NLC Formulation

Kaur

et al. 2017

Int J App Pharm

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Objective: The aim of the present work was to develop a simple, rapid, accurate and economical UV-visible spectrophotometric method for the determination of hydroquinone (HQ) in its pure form, marketed formulation as well as in the prepared nanostructured lipid carrier (NLC) systems and to validate the developed method.Methods: HQ was estimated at UV maxima of 289.6 nm in pH 5.5 phosphate buffer using UV-Visible double beam spectrophotometer. Following the guidelines of the International Conference on Harmonization (ICH), the method was validated for various analytical parameters like linearity, precision, and accuracy robustness, ruggedness, limit of detection, quantification limit, and formulation analysis. Results:The obtained results of the analysis were validated statistically. Recovery studies were performed to confirm the accuracy of the proposed method. In the developed method, linearity over the concentration range of 5-40 μg/ml of HQ was observed with the correlation coefficient of 0.998 and found in good agreement with Beer Lambert's law. The precision (intra-day and inter-day) of the method was found within official RCD limits (RSD<2%). Conclusion:The sensitivity of the method was assessed by determining the limit of detection and limit of quantification. It could be concluded from the results obtained that the purposed method for estimation of HQ in pure form, in the marketed ointment and in the prepared NLC-formulation was simple, rapid, accurate, precise and economical. It can be used successfully in the quality control of pharmaceutical formulations and for the routine laboratory analysis.

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“…Literature review revealed the determination of sitagliptin in dosage form either alone or combined form by UV spectrophotometry [13][14][15] , RP-HPLC 5,16-21 , UPLC 22 , tandem mass spectrometry 23,24 and capillary electrophoresis. 25 However, UV spectrophotometry is the simplest technique but it is deficient in accuracy and precision and needs relatively higher amount of analytes for detection.…”

Section: Sitagliptin Chemically [(R)mentioning

confidence: 99%

Quantitation of Sitagliptin in Drug Product by Validated Reversed Phase Liquid Chromatographic Technique

Sultana

Hossain

Islam

et al. 2018

Dhaka Univ. J. Pharm. Sci

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ABSTRACT:A novel reversed phase ultra-high performance liquid chromatographic (RP-UHPLC) method was developed for the estimation of sitagliptin in pharmaceutical dosage form. Separation was done by a X-bridge C18 column (4.6 i.d.× 150 mm, 5 μm particle size) with a flow rate of 1 ml/min using phosphate buffer (pH 6) and acetonitrile (70:30, v/v) as mobile phase at 268 nm using photodiode array plus (PDA+) detector. The retention time was found at 4.607 min. The developed method was validated as per the requirements of ICH-Q2B guidelines for specificity, system suitability, linearity, precision, accuracy, sensitivity and robustness. The linear regression analysis data for the linearity plot showed correlation coefficient values of 0.999 with LOD value of 0.06 µg/ml and LOQ of 0.225 µg/ml. The relative standard deviation (%RSD) for inter-day and intra-day precision was not more than 2.0%. The method was found to be accurate with percentages recovery of 98.50±0.03 to 99.70±0.05 and the % RSD was less than 2. The results showed that the proposed method is highly convenient for routine analysis of sitagliptin.

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Development and validation of the UV-spectrophotometric method for determination of terbinafine hydrochloride in bulk and in formulation

Cited by 51 publications

References 7 publications

Development and Validation of Uv-Spectrophotometric Methods for Determination of Gemcitabine Hydrochloride in Bulk and Polymeric Nanoparticles

Development and Validation of Uv-Spectrophotometric Methods for Determination of Gemcitabine Hydrochloride in Bulk and Polymeric Nanoparticles

Development and Validation of Uv-Spectrophotometric Method for Estimation of Hydroquinone in Bulk, Marketed Cream and Preapared NLC Formulation

Quantitation of Sitagliptin in Drug Product by Validated Reversed Phase Liquid Chromatographic Technique

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