Research Journal of Pharmacy and Technology

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Development and Validation of a Rp-uhplc Method for Estimation Of Gliclazide Loaded Microsphere


Affiliations
1 Girijananda Chowdhury Institute of Pharmaceutical Science, Tezpur, Assam – 784501., India
2 Assam Science and Technology University, Jalukbari, Guwahati, Assam-781013., India
3 NETES Institute of Pharmaceutical Science, Mirza, Kamrup, Assam-781125., India
     

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Objective: The objective of the current work is to develop and validate a simple yet effective, efficient and reproducible RP-UHPLC method for the determination of Gilcazide loaded in a microsphere formulation. Methods: The chromatographic analysis was carried out on Thermo Scientific (Dionex Ultra 3000plus) UHPLC using a stainless steel YMC C8 column (25cm × 4mm) packed with endcapped octylsilane bonded to porous silica (4μm) in isocratic elution mode using phosphate buffer pH 3.4 and HPLC grade acetonitrile in the ratio of 20: 80 (v/v) as eluent. The flow rate was adjusted as 1ml/min and eluent was detected at 230 nm. The retention time was observed at 1.9 min. Results: The linear dynamic range for the developed UHPLC method was found in the concentration range of 2-10μg/ml and percentage recovery was in the range of 94%-98%. Drug Entrapment Efficiency Data of Gliclazide loaded microsphere was found to be 93.72% Conclusion: In this RP– UHPLC method, the linearity was within the range of 2–10μg/mL and the validation parameters were within the limits was performed as per ICH guidelines. The % Drug entrapment Efficiency of the Gliclazide loaded microsphere was found to be 93.72 % which was satisfactory.

Keywords

Gliclazide, RP-UHPLC, Validation, Microsphere, Drug Entrapment Efficiency.
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  • Sarkar A, Tiwari A, Bhasin PS et al. Pharmacological and pharmaceutical profile of gliclazide: A review, J. Appl. Pharm. Sci. 1; 2011: 11–19.

  • Delrat P, Paraire M, Jochemsen R. Complete bioavailability and lack of food-effect on pharmacokinetics of gliclazide 30 mg modified release in healthy volunteers, Biopharm. Drug Dispos. 23; 2002: 151–157.

  • ICH, Q2 (R1) validation of analytical procedures: text and methodology, Proceedings of the International Conference on Harmonization, November 1996.

  • ICH, Q1A (R2) stability testing of new drug substances and products, Proceedings of the International Conference on Harmonization, November 1996.

  • Donnell PB, McGinity JW. Preparation of microspheres by the solvent evaporation technique, Adv. Drug Deliv. Rev. 28; 1997: 25–42.

  • Garud N, Garud A, Jain N. Formulation design and in-vitro evaluation of metformin microspheres using ionotropic gelation technique. J. Pharm. Res. 4(7); 2011: 2103-2106.

  • Lachman L, Lieberman H, Kanig J. The theory and practice of industrial pharmacy, 4th Edition, Varghese Publishing House, Dadar, Bombay. 1991: 183-184.

  • Badhana S, Garud N, Garud A. Colon Specific Drug Delivery of Mesalamine using Eudragit S100-coated chitosan microspheres for the treatment of ulcerative colitis. International Current Pharmaceutical Journal 2(3); 2013: 42-48.

  • Chaudhary A, Garud N, Garud A, Formulation and in-vitro characterization of floating drug delivery system of Nateglinide. Am. J. PharmTech. Res. 3(2); 2013: 477-486.

  • Garud N, Garud A. Preparation and In-vitro Evaluation of Metformin Microspheres using Non-aqueous Solvent Evaporation Technique, Trop. J. Pharm. Res. 11(4); 2012: 577-583.

  • Delrat P, Paraire M, Jochemsen R. Complete bioavailability and lack of food-effect on pharmacokinetics of gliclazide mg modified release in healthy volunteers, Biopharm. Drug Dispos. 23; 2002: 151–157.

  • Ahsanul H, Shahriar M, Parvin MN et al. Validated RP-HPLC Method for Estimation of Ranitidine Hydrochloride, Domperidone and Naproxen in Solid Dosage Form. Asian. J. Pharm. Ana. 1(3); 2011: 59-63.

  • Swapna J, Madhu C, Srivani M et al.Analytical Method Development and Method Validation for the Simultaneous Estimation of Metformin hydrochloride and Pioglitazone hydrochloride in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2(3); 2012: 85-89.

  • Manoranjan S, Sharada N, Venkateswarlu G, et al. A New Analytical Method Development and Validation for Estimation of Ciprofloxacin in Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2(4); 2012: 116-117.

  • Revathi R., Venkata SP, Koteswara R et al. Development and Validation of RP-HPLC Method for Content Analysis of Didanosine in Dosage Form. Asian J. Pharm. Ana. 2(4);2012: 118-121.

  • Renu S, Badri PN, Mahendra KN et al. Development and Validation of Simultaneous Estimation Method for Amoxycillin Trihydrate and Tinidazole in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 3(2); 2013: 66-71.

  • Bhavya B, Nagaraju P, Mounika V et al. Stability Indicating RPHPLC Method Development and Validation for Simultaneous Estimation of Albendazole and Ivermectin in Pharmaceutical Dosage form. Asian J. Pharm. Ana. 7(1); 2017: 6-14.

  • Sushil DP, Amurutkar SV, Upasani CD. Development and Validation of Stability Indicating RP-HPLC Method for Empagliflozin. Asian J. Pharm. Ana. 6(4); 2016: 201-206.

  • Kirthi A, Shanmugam R, Mohana LS et al. Analytical Method Development and Validation of a Stability-indicating RP-HPLC Method for the Analysis of Danazol in Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 6(4); 2016: 227-234.

  • Kumaraswamy G, Kumar DS, Praveen J et al. RP-HPLC Method Development and Validation for Simultaneous Estimation of Lignocaine Hydrochloride and Clotrimazole Hydrochloride in Ear Drops. Asian J. Pharm. Ana. 7(3); 2017: 163-168.

  • Khan H, Ali J. UHPLC: Applications in Pharmaceutical Analysis. Asian J. Pharm. Ana. 7(2); 2017: 124-131.


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  • Development and Validation of a Rp-uhplc Method for Estimation Of Gliclazide Loaded Microsphere

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Authors

Abdul Baquee Ahmed
Girijananda Chowdhury Institute of Pharmaceutical Science, Tezpur, Assam – 784501., India
Ripunjoy Bordoloi
Assam Science and Technology University, Jalukbari, Guwahati, Assam-781013., India
Kunal Bhattacharya
NETES Institute of Pharmaceutical Science, Mirza, Kamrup, Assam-781125., India

Abstract


Objective: The objective of the current work is to develop and validate a simple yet effective, efficient and reproducible RP-UHPLC method for the determination of Gilcazide loaded in a microsphere formulation. Methods: The chromatographic analysis was carried out on Thermo Scientific (Dionex Ultra 3000plus) UHPLC using a stainless steel YMC C8 column (25cm × 4mm) packed with endcapped octylsilane bonded to porous silica (4μm) in isocratic elution mode using phosphate buffer pH 3.4 and HPLC grade acetonitrile in the ratio of 20: 80 (v/v) as eluent. The flow rate was adjusted as 1ml/min and eluent was detected at 230 nm. The retention time was observed at 1.9 min. Results: The linear dynamic range for the developed UHPLC method was found in the concentration range of 2-10μg/ml and percentage recovery was in the range of 94%-98%. Drug Entrapment Efficiency Data of Gliclazide loaded microsphere was found to be 93.72% Conclusion: In this RP– UHPLC method, the linearity was within the range of 2–10μg/mL and the validation parameters were within the limits was performed as per ICH guidelines. The % Drug entrapment Efficiency of the Gliclazide loaded microsphere was found to be 93.72 % which was satisfactory.

Keywords


Gliclazide, RP-UHPLC, Validation, Microsphere, Drug Entrapment Efficiency.

References