|
| | | Year : 2008 | Volume : 2 | Issue : 4 | Page : 225-227 | | | Spectrophotometric estimation of pioglitazone hydrochloride in tablet dosage form | | | Pawan K Basniwal1, Prabhat K Srivastava2, Deepti Jain3
1 L.B.S. College of Pharmacy, Jaipur, Rajasthan, India
2 Department of Pharmaceutics, Banaras Hindu University, Varanasi, UP, India
3 School of Pharmaceutical Sciences, Rajiv Gandhi Technical University, Bhopal, MP, India
Click here for correspondence address and email | |      | |  Abstract | | | Two simple, rapid, and precise methods - linear regression equation (LRE) and standard absorptivity - were developed and validated for the estimation of pioglitazone hydrochloride in tablet dosage form. The maximum absorbance (lmax ) of pioglitazone hydrochloride was found to be 269.8 nm in methanol:water:hydrochloric acid (250:250:1). Beer-Lambert law was obeyed in the concentration range of 10-50 µg/ml, and the standard absorptivity was found to be 253.97 dl/g/cm. Both the methods were validated for linearity, accuracy, precision (days, analysts, and instrument variation), and robustness (solvent composition). The numerical values for all parameters lie within the acceptable limits. Pioglitazone hydrochloride was estimated in the range of 99.58-99.97% by LRE method and 100.25-100.75% by standard absorptivity method. At 99% confidence limit, the F-test value for the methods was found to be 1.8767. Keywords: Linear regression equation, standard absorptivity, pioglitazone hydrochloride, spectrophotometric estimation How to cite this article:
Basniwal PK, Srivastava PK, Jain D. Spectrophotometric estimation of pioglitazone hydrochloride in tablet dosage form. Asian J Pharm 2008;2:225-7 |
| Introduction | |  |
Pioglitazone hydrochloride, chemically [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl] methyl]-2, 4]thiazolidine-dione monohydrochloride, is thiazolidine-dione derivative that highly selective agonist for peroxisome proliferator-activated receptor gamma (PPAR) and is used as an adjunct to diet to improve glycemic control in patient with type 2 diabetes (non-insulin-dependent diabetes mellitus). The literature survey reveals that chromatographic methods are reported for simultaneous estimation of pioglitazone and its metabolites in human plasma, human serum, and urine. There is also simultaneous estimation of pioglitazone and glimpiride by chromatographic method, but no spectrophotometric is yet reported. [1],[2],[3],[4],[5],[6] Present work deals with the development of two spectrophotometric methods - linear regression equation (LRE) and standard absorptivity - and the validation of these developed methods according to the ICH guidelines to estimate pioglitazone hydrochloride in dosage form.
| Materials and Methods | | |
Materials
UV1700 series (Shimadzu, Japan) and UV vis double beam spectrophotometer 2201 (Systronic, Ahemadabad) were used for work working standard of pioglitazone was gift sample from Aristo Pharmaceuticals (Mandideep, MP, India) and tablets were procured from the local market (Pioglar-15; Ranbaxy Laboratory Ltd., Goa). Methanol (AR grade) and hydrochloric acid were from Merck Limited (Mumbai, India).
Linear regression equation method
Accurately weighed about 100 mg of pioglitazone hydrochloride was dissolved in 100 ml solvent system (methanol:water:hydrochloric acid = 250:250:1) to obtain 1000 µg/ml concentration of drug (stock A). Stock A (10 ml) was diluted up to 100 ml with solvent system to obtain 100 µg/ml concentration (Stock B). Aliquots of Stock B were diluted to obtain concentrations of 10, 20, 30, 40, and 50 µg/ml of pioglitazone hydrochloride. All dilutions were scanned from 300 to 200 nm against solvent system as blank [Figure 1] and their absorbance were observed at 269.8 nm [Figure 2]. The LRE was developed as ABC = 0.0256C + 0.000, where ABC = absorbance and C = concentration of dilutions in µg/ml, with the correlation coefficient r 2 = 0.9998.
Standard absorptivity method
Five dilutions were prepared in triplicate and the absorbance was observed at 269.8 nm. The standard absorptivity A (1%, 1 cm) and molar extinction coefficient e were calculated from the above observations [Table 1].
Validation
As per the ICH guidelines, [7],[8] six dilutions in three replicates were used to validate the methods for linearity, accuracy (by recovery studies), repeatability, intermediate precision (days, analysts, and instruments), robustness, and statistical parameters were calculated [Table 2].
Assay of tablets
Twenty tablets were weighed and finely powdered. Powder equivalent to 100 mg of pioglitazone hydrochloride was dissolved in 50 ml methanol by heating on water bath at 40°C for 30 min and volume made up to 100 ml with solvent system. Solution was filtered through Watmann paper no. 41 to obtain stock P. Stock P (10 ml) was diluted to obtain stock Q and aliquots of it were diluted to get sample concentrations in the range of linearity. Concentrations of sample solution were observed in multipoint calibration curve of quantitative mode at 269.8 nm by LRE method. Concentrations of sample solution were also calculated by using standard absorptivity [(1%, 1 cm) = 253.97 dl/g/cm and molar extinction coefficient (e = 9978.35 l/mol/cm) [Table 3].
| Results and Discussion | | |
In 50% aqueous methanol, pioglitazone hydrochloride gives zig-zag spectra and on the addition of hydrochloric acid it shift to characteristic Gaussian spectra accompanying accessible pattern for pioglitazone hydrochloride. For complete extraction of drug from tablet dosage form, methanol solution was heated on water bath at 40°C for 30 min. Pioglitazone hydrochloride was estimated within 99.58-99.97% with 0.1976 standard deviation by LRE method. By standard absorptivity method, it was estimated within 100.25-100.75% with 0.2707 standard deviation. The calculated value of F (1.8767) is very less than the theoretical value at 99% confidence limit; thus, the methods have comparable precisions.
Hence, the developed methods for pioglitazone hydrochloride are quite simple, rapid, and economical with acceptable limits of accuracy, precision, reproducibility, and robust to slight variation in experimental conditions. Therefore, methods may be useful for routine analysis of pioglitazone hydrochloride as bulk drug, in dosage form and dissolution studies in pharmaceutical industries.
| References | | |
| 1. | Sweetman SC, editors. In: Martindale: The complete drug reference, 33 rd ed. Vol. I, USA: Pharmaceutical Press; 2002. p. 353.  | | 2. | Zhog WZ, Williams ME. Simultaneous quantitation of pioglitazone and its metabolites in human serum by liquid chromatography and solid-phase extraction. J Pharm Biomed Ana 1996;14:465-73. | | 3. | Yamashita K, Muarakami H, Okuda T, Motohashi M. High-performance liquid chromatographic determination of pioglitazone and its metabolites in human serum and urine. J Chrom 1996;677:141-6. | | 4. | John-Lin Z, Ji W, Desai-Karieger D, Shum L. Simultaneous determination of pioglitazone and its two active metabolites in human plasma by L-MS-MS. J Pharm Biomed Ana 2003;33:101-8. | | 5. | Kolte BL, Raut BB, Deo AA, Begaol MA, Sinde DB. Simultaneous high-performance chromatographic determination of piogliatzone and metformin in pharmaceutical dosage form. J Chrom 2004;42:27-31. | | 6. | Sane RT, Menon SN, Inamolar S, Mote M, Gundi G. Simultaneous determination of pioglitazone and glimpiride by high-performance liquid chromatography. Chromatographia 2004;59:451. | | 7. | ICH. Text on Validation of Analytical Procedures, International conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use, Geneva: Jul 2000. | | 8. | ICH. Validation of Analytical Procedure: Methodology, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use, Geneva: Jul 2000. |
Correspondence Address:
Pawan K Basniwal
L.B.S. College of Pharmacy, Jaipur, Rajasthan
India
DOI: 10.4103/0973-8398.45035
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3] | |
| | | | | | | | | | | |
| Article Access Statistics | | | Viewed | 3355 | | | Printed | 119 | | | Emailed | 4 | | | PDF Downloaded | 568 | | | Comments | [Add] | | | | 
|
