Asian Journal of Research in Chemistry

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

A new Validated UV-visible Spectrophotometric Method for the Estimation of Pregabalin in its pure and dosage form using Bromophenol blue


Affiliations
1 Grace College of Pharmacy, Kodunthirapully P.O, Palakkad, Kerala – 678004., India
     

   Subscribe/Renew Journal


A new simple, accurate precise, cost effective, rapid and sensitive UV-Visible spectrophotometric method was developed for the estimation of Pregabalin in its pure and dosage form using Bromophenol blue. The developed method was validated as per ICH guideline in terms of linearity, accuracy, precision, ruggedness, LOD and LOQ. In this method the solvent used for the preparation of Pregabalin was distilled water. The method is based on the formation of brown colored ion-pair complex of Pregabalin with Bromophenol Blue reagent. The ion pair complex was produced in presence of Acid Phthalate Buffer of pH 3. The developed brown colour was stable at room temperature. The developed brown coloured complex showed maximum absorbance at 592nm. Linearity was found in the concentration range of 50, 60, 70, 80 and 90µg/ml with regression coefficient value 0.995. Precision studies for intra-day and inter-day shows that percentage relative standard deviation was within range of acceptable limit. The recovery studies were carried out at three percentage levels that is 50%, 100% and 150% levels. The results shows that the method was found to be accurate. The limit of detection (LOD) was found to be 10.91µg/ml and limit of quantification (LOQ) was found to be 33.06µg/ml. A ruggedness study was carried out using different analysts; assure that the method was rugged. Hence the method can be applied for routine quality control of the drug.

Keywords

Pregabalin, Bromophenol blue, Acid phthalate buffer, Ruggedness, Ion-pair complex.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Indian Pharmacopoeia 2018- Volume 2, The Indian Pharmacopoeia Commission, Ghaziabad, Page No: 2989-2991

  • The Merk Index – 13th edition, The Merk Research Laboratories division of Merk & Co., INC

  • http://pubchem.ncbi.nlm.nih.gov/compound/pregabalin

  • Ahmed G. Helmy, Fatma M. Abdel-Gawad, Eman F. Mohamed. Spectrophotometric Study on Determination of Aripiprazole in Tablets by Charge-Transfer and Ion-Pair Complexation Reactions with Some Acceptors. Asian J. Pharm. Ana. 2(1): Jan.-Mar. 2012; Page 12-19.

  • Santosh S. Chhajed a, Sandeep S. Sonawane, Akshada P. Pingle, NeelamDashputre, Sakshi, Sanjay J. Kshirsagara. Development and Validation of UV Spectrophotometric Method for Estimation of Pregabalin. Asian J. Pharm. Ana. 2019; 9(1):15-18.

  • M. Chennaiah, T. Veeraiah, T. Charan Singh, G. Venkateshwarlu. Extractive Spectrophotometric Methods for Determination of Pioglitazone Hydrochloride Using Acidic Triphenylmethane Dyes. Asian J. Research Chem. 4(6): June, 2011; Page 971-975.

  • S. Ashutosh Kumar, Manidipa Debnath, J. V. L. N. Seshagiri Rao, D. Gowri Sankar. A new, simple, sensitive, accurate and rapid analytical method development and validation for simultaneous estimation of Pregabalin, Mecobalamin and Alpha Lipoic Acid in bulk as well as in pharmaceutical dosage form by using RP-HPLC. Asian J. Research Chem. 7(4): April 2014; Page 426-433.

  • Cheenu G, Richa P, Afzal H et al. Development and validation of Ninhydrin based calorimetric assay for determination of Pregabalin in different dissolution medium. Eurasian Journal of Analytical Chemistry, 2013;8(2):92-98.

  • Mohamed R, Mona SE, Alik A et al. Spectrophotometric determination of Pregabalin using NED as labelling reagent. International Journal of Pharmacy and Biological Science. 2015;5(2):152-162.

  • Sowjanya K Thejaswiri CI, Guru Padayya BM et al.

  • Spectrophotometric determination of Pregabalin using Gibbs and MBTH reagent in pharmaceutical dosage form. Der Pharma Chemica, 2011;3(1):112-122.

  • Mohamed IW, Fathallah FB, Nahed MEI et al. Utility of certain nucleophilic aromatic substitution reaction for the assay of Pregabalin in capsule. Chemistry Central Journal, 2011;5(10):1-10.

  • Abdul Aziz Ramadan, Hasna Mandil, Souad Zeino. Spectrophotometric Determination of Glimepiride in Pure and Pharmaceutical Formulations Using Bromophenol Blue and Thymol Blue. Research J. Pharm. and Tech. 2019; 12(3): 11691177.

  • Nour Nashed, Saleh Trefi, Amir AlhajSakur. Validated Direct Spectrophotometric Methods for Determination of Cefpodoximeproxetil using Sulphonphtalein Acid Dyes. Research J. Pharm. and Tech 2018; 11(6): 2525-2530.

  • Y. Haribabu, Sheeja Velayudhan Kutty, Vidhya P.M., Greeshma S. Extractive Spectrophotometric Determination of Ofloxacin and Tinidazole with Bromophenol Blue. Research J. Pharm. and Tech 6(7): July 2013; Page 726-730

  • Sreekanth. D, P. Ramya, Vishwanadham. Y, Vanitha. R. Development and Method Validation of RP-HPLC For Simultaneous Determination of Pregabalin and Methylcobalamin in Pure and Pharmaceutical Dosage Form. Asian J. Research Chem. 2017; 10(4):557-565.

  • Amir Alhaj Sakur, Shaza Affas. Direct Spectrophotometric Determination of Sildenafil Citrate in Pharmaceutical Preparations Via Complex Formation with Two sulphonphthalein acid dyes.

  • Research J. Pharm. and Tech. 2017; 10(4): 1191-1196.

  • Abdul Aziz Ramadan, Hasna Mandil, Rasha Shamseh. Development and Validation of Spectrophotometric Determination of Cefpodoxime Proxetil in Pure Form and Pharmaceutical Formulation through Ion-Pair Complex Formation Using Bromocresol Purple. Research J. Pharm. and Tech. 2017; 10(3): 843-851.

  • Validation of compendial assays-Guidelines Pharmacopoeial Conversation, Rockville, MD, 1985, 25-36


Abstract Views: 290

PDF Views: 0




  • A new Validated UV-visible Spectrophotometric Method for the Estimation of Pregabalin in its pure and dosage form using Bromophenol blue

Abstract Views: 290  |  PDF Views: 0

Authors

Swapna A Surendran
Grace College of Pharmacy, Kodunthirapully P.O, Palakkad, Kerala – 678004., India
Akshay K
Grace College of Pharmacy, Kodunthirapully P.O, Palakkad, Kerala – 678004., India
Anaswara V
Grace College of Pharmacy, Kodunthirapully P.O, Palakkad, Kerala – 678004., India
Divya S
Grace College of Pharmacy, Kodunthirapully P.O, Palakkad, Kerala – 678004., India
Vismaya Venugopalan
Grace College of Pharmacy, Kodunthirapully P.O, Palakkad, Kerala – 678004., India

Abstract


A new simple, accurate precise, cost effective, rapid and sensitive UV-Visible spectrophotometric method was developed for the estimation of Pregabalin in its pure and dosage form using Bromophenol blue. The developed method was validated as per ICH guideline in terms of linearity, accuracy, precision, ruggedness, LOD and LOQ. In this method the solvent used for the preparation of Pregabalin was distilled water. The method is based on the formation of brown colored ion-pair complex of Pregabalin with Bromophenol Blue reagent. The ion pair complex was produced in presence of Acid Phthalate Buffer of pH 3. The developed brown colour was stable at room temperature. The developed brown coloured complex showed maximum absorbance at 592nm. Linearity was found in the concentration range of 50, 60, 70, 80 and 90µg/ml with regression coefficient value 0.995. Precision studies for intra-day and inter-day shows that percentage relative standard deviation was within range of acceptable limit. The recovery studies were carried out at three percentage levels that is 50%, 100% and 150% levels. The results shows that the method was found to be accurate. The limit of detection (LOD) was found to be 10.91µg/ml and limit of quantification (LOQ) was found to be 33.06µg/ml. A ruggedness study was carried out using different analysts; assure that the method was rugged. Hence the method can be applied for routine quality control of the drug.

Keywords


Pregabalin, Bromophenol blue, Acid phthalate buffer, Ruggedness, Ion-pair complex.

References