Simultaneous determination of pioglitazone and glimepiride in bulk drug and pharmaceutical dosage form by RP-HPLC method

A. Karthik, G. Subramanian, C. Mallikarjuna Rao, Krishnamurthy Bhat, A. Ranjithkumar, P. Musmade, M. Surulivelrajan, K. Karthikeyan, N. Udupa

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49 Citations (Scopus)

Abstract

A simple, fast, and precise reverse phase, isocratic HPLC method was developed for the separation and quantification of pioglitazone and glimepiride in bulk drug and pharmaceutical dosage form. The quantification was carried out using Inertsil ODS (250 × 4.6 mm, 5μ) column and mobile phase comprised of acetonitrile and ammonium acetate (pH 4.5; 20mM) in proportion of 60:40 (v/v). The flow rate was 1.0 ml/min and the effluent was monitored at 230 nm. The retention time of pioglitazone and glimepiride were 7.0±0.1 and 10.2±0.1 min respectively. The method was validated in terms of linearity, precision, accuracy, and specificity, limit of detection and limit of quantitation. Linearity of pioglitazone and glimepiride were in the range of 2.0 to 200.0μg/ml and 0.5-50μg/ml respectively. The percentage recoveries of both the drugs were 99.85% and 102.06% for pioglitazone and glimepiride respectively from the tablet formulation. The proposed method is suitable for simultaneous determination of pioglitazone and glimepiride in pharmaceutical dosage form and bulk drug.
Original languageEnglish
Pages (from-to)421-425
Number of pages5
JournalPakistan Journal of Pharmaceutical Sciences
Volume21
Issue number4
Publication statusPublished - 2008

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pioglitazone
glimepiride
Dosage Forms
High Pressure Liquid Chromatography
Pharmaceutical Preparations
Tablets
Limit of Detection

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@article{b470c59aaa9b40aea359895a69e316c3,
title = "Simultaneous determination of pioglitazone and glimepiride in bulk drug and pharmaceutical dosage form by RP-HPLC method",
abstract = "A simple, fast, and precise reverse phase, isocratic HPLC method was developed for the separation and quantification of pioglitazone and glimepiride in bulk drug and pharmaceutical dosage form. The quantification was carried out using Inertsil ODS (250 × 4.6 mm, 5μ) column and mobile phase comprised of acetonitrile and ammonium acetate (pH 4.5; 20mM) in proportion of 60:40 (v/v). The flow rate was 1.0 ml/min and the effluent was monitored at 230 nm. The retention time of pioglitazone and glimepiride were 7.0±0.1 and 10.2±0.1 min respectively. The method was validated in terms of linearity, precision, accuracy, and specificity, limit of detection and limit of quantitation. Linearity of pioglitazone and glimepiride were in the range of 2.0 to 200.0μg/ml and 0.5-50μg/ml respectively. The percentage recoveries of both the drugs were 99.85{\%} and 102.06{\%} for pioglitazone and glimepiride respectively from the tablet formulation. The proposed method is suitable for simultaneous determination of pioglitazone and glimepiride in pharmaceutical dosage form and bulk drug.",
author = "A. Karthik and G. Subramanian and {Mallikarjuna Rao}, C. and Krishnamurthy Bhat and A. Ranjithkumar and P. Musmade and M. Surulivelrajan and K. Karthikeyan and N. Udupa",
note = "Cited By :47 Export Date: 10 November 2017 Correspondence Address: Karthik, A.; Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal, India; email: millinkarthik@yahoo.co.in Chemicals/CAS: glimepiride, 93479-97-1; pioglitazone, 105355-27-9, 111025-46-8; Dosage Forms; Drug Combinations; glimepiride, 93479-97-1; Hypoglycemic Agents; pioglitazone, 111025-46-8; Sulfonylurea Compounds; Thiazolidinediones References: Chakradhar, L., Kallem, R., Karthik, A., Sundari, B.T., Ramesh, S., Mullangi, R., Srinivas, N.R., A rapid and highly sensitive method for the determination of Glimepiride in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry-application to preclinical Pharmacokinetic study (2007) J. Biomed. Chromatogr., 22, pp. 58-63; Eldeep, S., Schepers, U., W{\"a}tzig, H., Fast HPLC method for the determination of glimepiride, glibenclamide, and related substances using monolithic column and flow program (2006) J. Sep. Sci., 29, pp. 1571-1577; ICH draft guidelines on validation of analytical procedures: Definitions and terminology (1995) Federal Register, 60, p. 11260. , IFPMA, Switzerland; Jedlicka, A., Klimes, J., Grafnetterova, T., Reversed-phase HPLC methods for purity test and assay of pioglitazone hydrochloride in tablets (2004) Pharmazie., 59, pp. 178-182; Khan, M.A., Sinha, S., Vartak, S., Bhartiya, A., Kumar, S., LC determination of Glimepiride and its related impurities (2005) J. Pharm. Biomed. Anal., 39, pp. 928-943; Kolte, B.L., Raut, B.B., Deo, A.A., Bagool, M.A., Shinde, D.B., Simultaneous high-performance liquid chromatographic determination of pioglitazone and metformin in pharmaceutical-dosage form (2004) J. Chromatogr. Sci., 42, pp. 27-31; Kovar{\'i}kov{\'a}, P., Klimes, J., Dohnal, J., Tisovsk{\'a}, L., HPLC study of glimepiride under hydrolytic stress conditions (2004) J. Pharm. Biomed. Anal., 36, pp. 205-209; Reynolds, J.E.F., (1989) Martindale, the Extra Pharmacopoeia, p. 1240. , 29th Edn., The Pharmaceutical Press, London; Salem, I.I., Idrees, J., Al Tamimi, J.I., Determination of glimepiride in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry (2004) J. Chromatogr. B. Analyt Technol. Biomed. Life Sci., 799, pp. 103-109; Sripalakit, P., Neamhom, P., Saraphanchotiwitthaya, A., High-performance liquid chromatographic method for the determination of pioglitazone in human plasma using ultraviolet detection and its application to a pharmacokinetic study (2006) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 843, pp. 164-169; (1996) United States Pharmacopoeia, , 23rd Edn, The USP convention, Inc, Rockville, M.D; Venkatesh, P., Harisudhan, T., Choudhury, H., Mullangi, R., Srinivas, N.R., Simultaneous estimation of six anti-diabetic drugs-glibenclamide, gliclazide, glipizide, pioglitazone, repaglinide and rosiglitazone: Development of a novel HPLC method for use in the analysis of pharmaceutical formulations and its application to human plasma assay (2006) J. Biomed. Chromatogr., 20, pp. 1043-1048; Xue, Y.J., Turner, K.C., Meeker, J.B., Pursley, J., Arnold, M., Unger, S., Quantitative determination of pioglitazone in human serum by direct-injection highperformance liquid chromatography mass spectrometry and its application to a bioequivalence study (2003) J. Chromatogr. B. Analyt. Technol. Biomed. Life Sci., 795, pp. 215-226; Yao, J., Shi, Y.Q., Li, Z.R., Jin, S.H., Development of a RP-HPLC method for screening potentially counterfeit anti-diabetic drugs (2007) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 853, pp. 254-259",
year = "2008",
language = "English",
volume = "21",
pages = "421--425",
journal = "Pakistan Journal of Pharmaceutical Sciences",
issn = "1011-601X",
publisher = "Pakistan Journal of Pharmaceutical Sciences",
number = "4",

}

Simultaneous determination of pioglitazone and glimepiride in bulk drug and pharmaceutical dosage form by RP-HPLC method. / Karthik, A.; Subramanian, G.; Mallikarjuna Rao, C.; Bhat, Krishnamurthy; Ranjithkumar, A.; Musmade, P.; Surulivelrajan, M.; Karthikeyan, K.; Udupa, N.

In: Pakistan Journal of Pharmaceutical Sciences, Vol. 21, No. 4, 2008, p. 421-425.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Simultaneous determination of pioglitazone and glimepiride in bulk drug and pharmaceutical dosage form by RP-HPLC method

AU - Karthik, A.

AU - Subramanian, G.

AU - Mallikarjuna Rao, C.

AU - Bhat, Krishnamurthy

AU - Ranjithkumar, A.

AU - Musmade, P.

AU - Surulivelrajan, M.

AU - Karthikeyan, K.

AU - Udupa, N.

N1 - Cited By :47 Export Date: 10 November 2017 Correspondence Address: Karthik, A.; Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal, India; email: millinkarthik@yahoo.co.in Chemicals/CAS: glimepiride, 93479-97-1; pioglitazone, 105355-27-9, 111025-46-8; Dosage Forms; Drug Combinations; glimepiride, 93479-97-1; Hypoglycemic Agents; pioglitazone, 111025-46-8; Sulfonylurea Compounds; Thiazolidinediones References: Chakradhar, L., Kallem, R., Karthik, A., Sundari, B.T., Ramesh, S., Mullangi, R., Srinivas, N.R., A rapid and highly sensitive method for the determination of Glimepiride in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry-application to preclinical Pharmacokinetic study (2007) J. Biomed. Chromatogr., 22, pp. 58-63; Eldeep, S., Schepers, U., Wätzig, H., Fast HPLC method for the determination of glimepiride, glibenclamide, and related substances using monolithic column and flow program (2006) J. Sep. Sci., 29, pp. 1571-1577; ICH draft guidelines on validation of analytical procedures: Definitions and terminology (1995) Federal Register, 60, p. 11260. , IFPMA, Switzerland; Jedlicka, A., Klimes, J., Grafnetterova, T., Reversed-phase HPLC methods for purity test and assay of pioglitazone hydrochloride in tablets (2004) Pharmazie., 59, pp. 178-182; Khan, M.A., Sinha, S., Vartak, S., Bhartiya, A., Kumar, S., LC determination of Glimepiride and its related impurities (2005) J. Pharm. Biomed. Anal., 39, pp. 928-943; Kolte, B.L., Raut, B.B., Deo, A.A., Bagool, M.A., Shinde, D.B., Simultaneous high-performance liquid chromatographic determination of pioglitazone and metformin in pharmaceutical-dosage form (2004) J. Chromatogr. Sci., 42, pp. 27-31; Kovaríková, P., Klimes, J., Dohnal, J., Tisovská, L., HPLC study of glimepiride under hydrolytic stress conditions (2004) J. Pharm. Biomed. Anal., 36, pp. 205-209; Reynolds, J.E.F., (1989) Martindale, the Extra Pharmacopoeia, p. 1240. , 29th Edn., The Pharmaceutical Press, London; Salem, I.I., Idrees, J., Al Tamimi, J.I., Determination of glimepiride in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry (2004) J. Chromatogr. B. Analyt Technol. Biomed. Life Sci., 799, pp. 103-109; Sripalakit, P., Neamhom, P., Saraphanchotiwitthaya, A., High-performance liquid chromatographic method for the determination of pioglitazone in human plasma using ultraviolet detection and its application to a pharmacokinetic study (2006) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 843, pp. 164-169; (1996) United States Pharmacopoeia, , 23rd Edn, The USP convention, Inc, Rockville, M.D; Venkatesh, P., Harisudhan, T., Choudhury, H., Mullangi, R., Srinivas, N.R., Simultaneous estimation of six anti-diabetic drugs-glibenclamide, gliclazide, glipizide, pioglitazone, repaglinide and rosiglitazone: Development of a novel HPLC method for use in the analysis of pharmaceutical formulations and its application to human plasma assay (2006) J. Biomed. Chromatogr., 20, pp. 1043-1048; Xue, Y.J., Turner, K.C., Meeker, J.B., Pursley, J., Arnold, M., Unger, S., Quantitative determination of pioglitazone in human serum by direct-injection highperformance liquid chromatography mass spectrometry and its application to a bioequivalence study (2003) J. Chromatogr. B. Analyt. Technol. Biomed. Life Sci., 795, pp. 215-226; Yao, J., Shi, Y.Q., Li, Z.R., Jin, S.H., Development of a RP-HPLC method for screening potentially counterfeit anti-diabetic drugs (2007) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 853, pp. 254-259

PY - 2008

Y1 - 2008

N2 - A simple, fast, and precise reverse phase, isocratic HPLC method was developed for the separation and quantification of pioglitazone and glimepiride in bulk drug and pharmaceutical dosage form. The quantification was carried out using Inertsil ODS (250 × 4.6 mm, 5μ) column and mobile phase comprised of acetonitrile and ammonium acetate (pH 4.5; 20mM) in proportion of 60:40 (v/v). The flow rate was 1.0 ml/min and the effluent was monitored at 230 nm. The retention time of pioglitazone and glimepiride were 7.0±0.1 and 10.2±0.1 min respectively. The method was validated in terms of linearity, precision, accuracy, and specificity, limit of detection and limit of quantitation. Linearity of pioglitazone and glimepiride were in the range of 2.0 to 200.0μg/ml and 0.5-50μg/ml respectively. The percentage recoveries of both the drugs were 99.85% and 102.06% for pioglitazone and glimepiride respectively from the tablet formulation. The proposed method is suitable for simultaneous determination of pioglitazone and glimepiride in pharmaceutical dosage form and bulk drug.

AB - A simple, fast, and precise reverse phase, isocratic HPLC method was developed for the separation and quantification of pioglitazone and glimepiride in bulk drug and pharmaceutical dosage form. The quantification was carried out using Inertsil ODS (250 × 4.6 mm, 5μ) column and mobile phase comprised of acetonitrile and ammonium acetate (pH 4.5; 20mM) in proportion of 60:40 (v/v). The flow rate was 1.0 ml/min and the effluent was monitored at 230 nm. The retention time of pioglitazone and glimepiride were 7.0±0.1 and 10.2±0.1 min respectively. The method was validated in terms of linearity, precision, accuracy, and specificity, limit of detection and limit of quantitation. Linearity of pioglitazone and glimepiride were in the range of 2.0 to 200.0μg/ml and 0.5-50μg/ml respectively. The percentage recoveries of both the drugs were 99.85% and 102.06% for pioglitazone and glimepiride respectively from the tablet formulation. The proposed method is suitable for simultaneous determination of pioglitazone and glimepiride in pharmaceutical dosage form and bulk drug.

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